National Drug Code (NDC) Sample List

Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. The FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory. The NDC contains over 97,000 entries; this list contains a small set of sample records illustrating the fields contained in the full list. View the API output for the full set of 11 fields contained in this dataset.

1,000 records

Proprietary Drug Name Generic Name Dosage Type Product Type Start Date End Date Primary Substance Marketing Category Application Number Numberator/Strength Active Ingredient
Acular Ketorolac Tromethamine Solution/ Drops HUMAN PRESCRIPTION DRUG 12/01/1992 01/01/1900 Ketorolac Tromethamine NDA NDA019700 5 mg/mL
ACULAR LS ketorolac tromethamine Solution/ Drops HUMAN PRESCRIPTION DRUG 08/19/2003 01/01/1900 Ketorolac Tromethamine NDA NDA021528 4 mg/mL
ACUVAIL ketorolac tromethamine Solution/ Drops HUMAN PRESCRIPTION DRUG 08/01/2009 01/01/1900 Ketorolac Tromethamine NDA NDA022427 4.5 mg/mL
ACZONE dapsone Gel HUMAN PRESCRIPTION DRUG 06/24/2009 01/01/1900 Dapsone NDA NDA021794 50 mg/g
Afrezza Insulin Human Powder, Metered HUMAN PRESCRIPTION DRUG 07/11/2014 01/01/1900 Insulin Human NDA NDA022472 4 42005
Afrezza Insulin Human Kit HUMAN PRESCRIPTION DRUG 07/11/2014 01/01/1900 NDA NDA022472
Afrezza Insulin Human Kit HUMAN PRESCRIPTION DRUG 07/11/2014 01/01/1900 NDA NDA022472
Afrezza Insulin Human Kit HUMAN PRESCRIPTION DRUG 07/11/2014 01/01/1900 NDA NDA022472
Albuminar-20 Albumin (Human) Solution PLASMA DERIVATIVE 01/06/2009 01/01/1900 Albumin Human BLA BLA103955 20 g/100mL
Albuminar-25 Albumin (Human) Solution PLASMA DERIVATIVE 01/06/2009 01/01/1900 Albumin Human BLA BLA103955 25 g/100mL
Albuminar-5 Albumin (Human) Solution PLASMA DERIVATIVE 01/06/2009 01/01/1900 Albumin Human BLA BLA103955 2.5 g/50mL
ALDACTAZIDE spironolactone and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/1978 01/01/1900 Hydrochlorothiazide; Spironolactone NDA NDA012616 25; 25 mg/1; mg/1
ALDACTAZIDE spironolactone and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/1978 01/01/1900 Hydrochlorothiazide; Spironolactone NDA NDA012616 50; 50 mg/1; mg/1
Aldactone spironolactone Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/21/1960 01/01/1900 Spironolactone NDA NDA012151 100 mg/1
Aldactone spironolactone Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/21/1960 01/01/1900 Spironolactone NDA NDA012151 50 mg/1
Aldactone spironolactone Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/21/1960 01/01/1900 Spironolactone NDA NDA012151 25 mg/1
Alimta Pemetrexed disodium Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 02/13/2004 01/01/1900 Pemetrexed Disodium Heptahydrate NDA NDA021462 500 mg/20mL
Alimta Pemetrexed disodium Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/15/2008 01/01/1900 Pemetrexed Disodium Heptahydrate NDA NDA021462 100 mg/4mL
ALOCRIL nedocromil sodium Solution/ Drops HUMAN PRESCRIPTION DRUG 02/03/2000 01/01/1900 Nedocromil Sodium NDA NDA021009 20 mg/mL
ALPHAGAN P brimonidine tartrate Solution/ Drops HUMAN PRESCRIPTION DRUG 07/10/2001 01/01/1900 Brimonidine Tartrate NDA NDA021262 1.5 mg/mL
ALPHAGAN P brimonidine tartrate Solution/ Drops HUMAN PRESCRIPTION DRUG 01/25/2006 01/01/1900 Brimonidine Tartrate NDA NDA021770 1 mg/mL
ALTABAX retapamulin Ointment HUMAN PRESCRIPTION DRUG 05/02/2007 01/01/1900 Retapamulin NDA NDA022055 10 mg/g
AMARYL glimepiride Tablet HUMAN PRESCRIPTION DRUG 06/18/2009 01/01/1900 Glimepiride NDA NDA020496 1 mg/1
AMARYL glimepiride Tablet HUMAN PRESCRIPTION DRUG 06/18/2009 01/01/1900 Glimepiride NDA NDA020496 2 mg/1
AMARYL glimepiride Tablet HUMAN PRESCRIPTION DRUG 06/18/2009 01/01/1900 Glimepiride NDA NDA020496 4 mg/1
Ambien zolpidem tartrate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/01/1993 01/01/1900 Zolpidem Tartrate NDA NDA019908 5 mg/1
Ambien zolpidem tartrate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/01/1993 01/01/1900 Zolpidem Tartrate NDA NDA019908 10 mg/1
Ambien zolpidem tartrate Tablet, Coated HUMAN PRESCRIPTION DRUG 09/19/2005 01/01/1900 Zolpidem Tartrate NDA NDA021774 6.25 mg/1
Ambien zolpidem tartrate Tablet, Coated HUMAN PRESCRIPTION DRUG 09/19/2005 01/01/1900 Zolpidem Tartrate NDA NDA021774 12.5 mg/1
AMINOHIPPURATE SODIUM aminohippurate sodium Injection, Solution HUMAN PRESCRIPTION DRUG 12/30/1944 01/01/1900 Aminohippurate Sodium NDA NDA005619 2 g/10mL
Amlodipine Besylate Amlodipine Besylate Tablet HUMAN PRESCRIPTION DRUG 07/09/2007 01/01/1900 Amlodipine Besylate ANDA ANDA077262 2.5 mg/1
Amlodipine Besylate Amlodipine Besylate Tablet HUMAN PRESCRIPTION DRUG 07/09/2007 01/01/1900 Amlodipine Besylate ANDA ANDA077262 5 mg/1
Amlodipine Besylate Amlodipine Besylate Tablet HUMAN PRESCRIPTION DRUG 07/09/2007 01/01/1900 Amlodipine Besylate ANDA ANDA077262 10 mg/1
Amyvid Florbetapir F 18 Injection, Solution HUMAN PRESCRIPTION DRUG 06/01/2012 01/01/1900 Florbetapir F-18 NDA NDA202008 51 mCi/mL
Anaprox naproxen sodium Tablet HUMAN PRESCRIPTION DRUG 09/04/1980 01/01/1900 Naproxen Sodium NDA NDA018164 275 mg/1
Anaprox DS naproxen sodium Tablet HUMAN PRESCRIPTION DRUG 09/04/1980 01/01/1900 Naproxen Sodium NDA NDA018164 550 mg/1
Androgel Testosterone Gel HUMAN PRESCRIPTION DRUG 03/14/2011 01/01/1900 Testosterone NDA NDA021015 10 mg/g
Androgel Testosterone Gel HUMAN PRESCRIPTION DRUG 03/14/2011 01/01/1900 Testosterone NDA NDA021015 10 mg/g
Androgel Testosterone Gel HUMAN PRESCRIPTION DRUG 04/29/2011 01/01/1900 Testosterone NDA NDA022309 16.2 mg/g
Androgel Testosterone Gel HUMAN PRESCRIPTION DRUG 03/14/2011 01/01/1900 Testosterone NDA NDA021015 10 mg/g
ANTIVENIN Latrodectus mactans Kit PLASMA DERIVATIVE 12/01/2014 01/01/1900 BLA BLA101062
ANTIVENIN (MICRURUS FULVIUS) antivenin (micrurus fulvius) Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/1967 01/01/1900 North American Coral Snake Antivenin (micrurus Fulvius) (equine) BLA BLA101099 1 g/10mL
Antivert MECLIZINE HYDROCHLORIDE Tablet HUMAN PRESCRIPTION DRUG 04/11/1997 01/01/1900 Meclizine Hydrochloride NDA NDA010721 12.5 mg/1
Antivert MECLIZINE HYDROCHLORIDE Tablet HUMAN PRESCRIPTION DRUG 04/11/1997 01/01/1900 Meclizine Hydrochloride NDA NDA010721 25 mg/1
Antivert MECLIZINE HYDROCHLORIDE Tablet HUMAN PRESCRIPTION DRUG 04/11/1997 01/01/1900 Meclizine Hydrochloride NDA NDA010721 50 mg/1
Aplenzin bupropion hydrobromide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 03/30/2009 03/31/2017 Bupropion Hydrobromide NDA NDA022108 174 mg/1
Aplenzin bupropion hydrobromide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 03/30/2009 03/31/2017 Bupropion Hydrobromide NDA NDA022108 348 mg/1
Aplenzin bupropion hydrobromide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 03/30/2009 01/01/1900 Bupropion Hydrobromide NDA NDA022108 522 mg/1
ARGATROBAN argatroban Injection, Solution HUMAN PRESCRIPTION DRUG 11/28/2000 01/01/1900 Argatroban NDA NDA020883 100 mg/mL
ARIXTRA fondaparinux sodium Injection, Solution HUMAN PRESCRIPTION DRUG 03/30/2005 10/31/2016 Fondaparinux Sodium NDA NDA021345 2.5 mg/.5mL
ARIXTRA fondaparinux sodium Injection, Solution HUMAN PRESCRIPTION DRUG 11/17/2004 11/30/2016 Fondaparinux Sodium NDA NDA021345 5 mg/.4mL
ARIXTRA fondaparinux sodium Injection, Solution HUMAN PRESCRIPTION DRUG 11/17/2004 11/30/2016 Fondaparinux Sodium NDA NDA021345 7.5 mg/.6mL
ARIXTRA fondaparinux sodium Injection, Solution HUMAN PRESCRIPTION DRUG 11/17/2004 09/30/2016 Fondaparinux Sodium NDA NDA021345 10 mg/.8mL
Aromasin exemestane Tablet HUMAN PRESCRIPTION DRUG 10/21/1999 01/01/1900 Exemestane NDA NDA020753 25 mg/1
ARRANON nelarabine Injection HUMAN PRESCRIPTION DRUG 01/19/2006 01/01/1900 Nelarabine NDA NDA021877 5 mg/mL
ARTHROTEC diclofenac sodium and misoprostol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/24/1997 01/01/1900 Diclofenac Sodium; Misoprostol NDA NDA020607 50; 200 mg/1; ug/1
ARTHROTEC diclofenac sodium and misoprostol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/24/1997 01/01/1900 Diclofenac Sodium; Misoprostol NDA NDA020607 75; 200 mg/1; ug/1
Astelin azelastine hydrochloride Spray, Metered HUMAN PRESCRIPTION DRUG 11/15/1996 11/30/2016 Azelastine Hydrochloride NDA NDA020114 137 ug/1
Astepro Azelastine Hydrochloride Spray, Metered HUMAN PRESCRIPTION DRUG 10/12/2009 01/01/1900 Azelastine Hydrochloride NDA NDA022371 205.5 ug/1
Atgam EQUINE THYMOCYTE IMMUNE GLOBULIN Injection, Solution HUMAN PRESCRIPTION DRUG 11/17/1981 01/01/1900 Equine Thymocyte Immune Globulin BLA BLA103676 50 mg/mL
Auvi-Q epinephrine Injection HUMAN PRESCRIPTION DRUG 11/15/2012 01/01/1900 Epinephrine NDA NDA201739 0.15 mg/1
Auvi-Q epinephrine Injection HUMAN PRESCRIPTION DRUG 11/15/2012 01/01/1900 Epinephrine NDA NDA201739 0.3 mg/1
AVAGE tazarotene Cream HUMAN PRESCRIPTION DRUG 01/07/2003 01/01/1900 Tazarotene NDA NDA021184 1 mg/g
Avalide irbesartan and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/2013 01/01/1900 Hydrochlorothiazide; Irbesartan NDA NDA020758 12.5; 150 mg/1; mg/1
Avalide irbesartan and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/2013 01/01/1900 Hydrochlorothiazide; Irbesartan NDA NDA020758 12.5; 300 mg/1; mg/1
Avapro irbesartan Tablet HUMAN PRESCRIPTION DRUG 01/01/2013 01/01/1900 Irbesartan NDA NDA020757 75 mg/1
Avapro irbesartan Tablet HUMAN PRESCRIPTION DRUG 01/01/2013 01/01/1900 Irbesartan NDA NDA020757 150 mg/1
Avapro irbesartan Tablet HUMAN PRESCRIPTION DRUG 01/01/2013 01/01/1900 Irbesartan NDA NDA020757 300 mg/1
AVC sulfanilamide Cream HUMAN PRESCRIPTION DRUG 12/01/2014 01/01/1900 Sulfanilamide NDA NDA006530 15 g/100g
AXIRON testosterone Solution HUMAN PRESCRIPTION DRUG 12/01/2010 01/01/1900 Testosterone NDA NDA022504 30 mg/1.5mL
AZACTAM AZTREONAM Injection, Solution HUMAN PRESCRIPTION DRUG 04/01/2010 01/01/1900 Aztreonam NDA NDA050632 1 g/50mL
AZACTAM AZTREONAM Injection, Solution HUMAN PRESCRIPTION DRUG 04/01/2010 01/01/1900 Aztreonam NDA NDA050632 2 g/50mL
AZACTAM AZTREONAM Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/01/2010 01/01/1900 Aztreonam NDA NDA050580 1 g/1
AZACTAM AZTREONAM Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/01/2010 01/01/1900 Aztreonam NDA NDA050580 2 g/1
AZELEX azelaic acid Cream HUMAN PRESCRIPTION DRUG 03/21/1996 01/01/1900 Azelaic Acid NDA NDA020428 0.2 g/g
Azulfidine Sulfasalazine Tablet HUMAN PRESCRIPTION DRUG 06/20/1950 01/01/1900 Sulfasalazine NDA NDA007073 500 mg/1
Azulfidine Sulfasalazine Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 06/20/1950 01/01/1900 Sulfasalazine NDA NDA007073 500 mg/1
Bacitracin Bacitracin Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 07/29/1948 01/01/1900 Bacitracin A ANDA ANDA060733 5000 [USP'U]/mL
Bacitracin Bacitracin Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 07/29/1948 01/01/1900 Bacitracin A ANDA ANDA060733 5000 [USP'U]/mL
Bacitracin Bacitracin Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 07/29/1948 01/01/1900 Bacitracin ANDA ANDA060733 50000 [iU]/9.8mL
Bacitracin Bacitracin Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 07/29/1948 01/01/1900 Bacitracin A ANDA ANDA060733 5000 [USP'U]/mL
BACTROBAN mupirocin Ointment HUMAN PRESCRIPTION DRUG 04/07/2000 01/01/1900 Mupirocin NDA NDA050591 20 mg/g
BACTROBAN mupirocin calcium Ointment HUMAN PRESCRIPTION DRUG 04/10/1996 01/01/1900 Mupirocin Calcium NDA NDA050703 20 mg/g
BACTROBAN mupirocin calcium Cream HUMAN PRESCRIPTION DRUG 01/23/1998 01/01/1900 Mupirocin Calcium NDA NDA050746 20 mg/g
Balsalazide Disodium Balsalazide Disodium Capsule HUMAN PRESCRIPTION DRUG 12/28/2007 01/01/1900 Balsalazide Disodium ANDA ANDA077806 750 mg/1
BARACLUDE entecavir Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/29/2005 01/01/1900 Entecavir NDA NDA021797 0.5 mg/1
BARACLUDE entecavir Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/29/2005 01/01/1900 Entecavir NDA NDA021797 1 mg/1
BARACLUDE entecavir Solution HUMAN PRESCRIPTION DRUG 03/29/2005 01/01/1900 Entecavir NDA NDA021798 0.05 mg/mL
BCG VACCINE BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN Injection, Powder, Lyophilized, For Solution VACCINE 06/21/1989 01/01/1900 Bacillus Calmette-guerin Substrain Tice Live Antigen BLA BLA103050 50 mg/1
BELSOMRA suvorexant Tablet, Film Coated HUMAN PRESCRIPTION DRUG 08/29/2014 01/01/1900 Suvorexant NDA NDA204569 5 mg/1
BELSOMRA suvorexant Tablet, Film Coated HUMAN PRESCRIPTION DRUG 08/29/2014 01/01/1900 Suvorexant NDA NDA204569 10 mg/1
BELSOMRA suvorexant Tablet, Film Coated HUMAN PRESCRIPTION DRUG 08/29/2014 01/01/1900 Suvorexant NDA NDA204569 15 mg/1
BELSOMRA suvorexant Tablet, Film Coated HUMAN PRESCRIPTION DRUG 08/29/2014 01/01/1900 Suvorexant NDA NDA204569 20 mg/1
BETAGAN levobunolol hydrochloride Solution/ Drops HUMAN PRESCRIPTION DRUG 07/24/1986 01/01/1900 Levobunolol Hydrochloride NDA NDA019219 5 mg/mL
BICNU carmustine Kit HUMAN PRESCRIPTION DRUG 06/01/2009 09/30/2015 NDA NDA017422
BiferaRx Iron Supplement Tablet HUMAN PRESCRIPTION DRUG 10/31/2012 01/01/1900 Cyanocobalamin; Folic Acid; Heme Iron Polypeptide; Iron Dextran UNAPPROVED DRUG OTHER 25; 1; 6; 22 ug/1; mg/1; mg/1; mg/1
BLEPHAMIDE sulfacetamide sodium and prednisolone acetate Ointment HUMAN PRESCRIPTION DRUG 01/01/1987 01/01/1900 Prednisolone Acetate; Sulfacetamide Sodium ANDA ANDA087748 2; 100 mg/g; mg/g
Boniva ibandronate sodium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 07/15/2002 01/01/1900 Ibandronate Sodium NDA NDA021455 150 mg/1
Boniva ibandronate sodium Injection, Solution HUMAN PRESCRIPTION DRUG 06/01/2011 01/01/1900 Ibandronate Sodium NDA NDA021858 3 mg/3mL
BOTOX onabotulinumtoxinA Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 12/15/1989 01/01/1900 Botulinum Toxin Type A BLA BLA103000 100 [USP'U]/1
BOTOX onabotulinumtoxinA Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/11/2010 01/01/1900 Botulinum Toxin Type A BLA BLA103000 200 [USP'U]/1
BOTOX Cosmetic onabotulinumtoxinA Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 07/15/2008 01/01/1900 Botulinum Toxin Type A BLA BLA103000 50 [USP'U]/1
BOTOX Cosmetic onabotulinumtoxinA Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 05/20/2008 01/01/1900 Botulinum Toxin Type A BLA BLA103000 100 [USP'U]/1
Butisol Sodium Butabarbital Sodium Solution HUMAN PRESCRIPTION DRUG 06/01/1978 06/30/2015 Butabarbital Sodium ANDA ANDA085380 30 mg/5mL
Butisol Sodium Butabarbital Sodium Tablet HUMAN PRESCRIPTION DRUG 08/01/1939 01/01/1900 Butabarbital Sodium NDA NDA000793 30 mg/1
CALAN verapamil hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 09/10/1984 01/01/1900 Verapamil Hydrochloride NDA NDA018817 80 mg/1
CALAN verapamil hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 09/10/1984 01/01/1900 Verapamil Hydrochloride NDA NDA018817 120 mg/1
CALAN SR verapamil hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 12/16/1986 01/01/1900 Verapamil Hydrochloride NDA NDA019152 240 mg/1
CALAN SR verapamil hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 03/06/1991 01/01/1900 Verapamil Hydrochloride NDA NDA019152 120 mg/1
CALAN SR verapamil hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 12/15/1989 01/01/1900 Verapamil Hydrochloride NDA NDA019152 180 mg/1
Calcitriol Calcitriol Capsule HUMAN PRESCRIPTION DRUG 03/27/2006 01/01/1900 Calcitriol ANDA ANDA076917 0.25 ug/1
Calcium Acetate Calcium Acetate Capsule HUMAN PRESCRIPTION DRUG 02/26/2008 01/01/1900 Calcium Acetate ANDA ANDA077728 667 mg/1
Camptosar irinotecan hydrochloride Injection, Solution HUMAN PRESCRIPTION DRUG 06/14/1996 01/01/1900 Irinotecan Hydrochloride NDA NDA020571 20 mg/mL
Camptosar irinotecan hydrochloride Injection, Solution HUMAN PRESCRIPTION DRUG 06/14/1996 01/01/1900 Irinotecan Hydrochloride NDA NDA020571 20 mg/mL
CANCIDAS CASPOFUNGIN ACETATE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/26/2001 01/01/1900 Caspofungin Acetate NDA NDA021227 5 mg/mL
CANCIDAS CASPOFUNGIN ACETATE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/26/2001 01/01/1900 Caspofungin Acetate NDA NDA021227 7 mg/mL
Cardura doxazosin mesylate Tablet, Multilayer, Extended Release HUMAN PRESCRIPTION DRUG 02/22/2005 01/01/1900 Doxazosin Mesylate NDA NDA021269 4 mg/1
Cardura doxazosin mesylate Tablet, Multilayer, Extended Release HUMAN PRESCRIPTION DRUG 02/22/2005 01/01/1900 Doxazosin Mesylate NDA NDA021269 8 mg/1
Cardura doxazosin mesylate Tablet HUMAN PRESCRIPTION DRUG 11/02/1990 01/01/1900 Doxazosin Mesylate NDA NDA019668 1 mg/1
Cardura doxazosin mesylate Tablet HUMAN PRESCRIPTION DRUG 11/02/1990 01/01/1900 Doxazosin Mesylate NDA NDA019668 2 mg/1
Cardura doxazosin mesylate Tablet HUMAN PRESCRIPTION DRUG 11/02/1990 01/01/1900 Doxazosin Mesylate NDA NDA019668 4 mg/1
Cardura doxazosin mesylate Tablet HUMAN PRESCRIPTION DRUG 11/02/1990 01/01/1900 Doxazosin Mesylate NDA NDA019668 8 mg/1
Caverject ALPROSTADIL Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 07/06/1995 01/01/1900 Alprostadil NDA NDA020379 20.5 ug/mL
Caverject ALPROSTADIL Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 07/06/1995 01/01/1900 Alprostadil NDA NDA020379 10.5 ug/mL
Caverject ALPROSTADIL Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 07/06/1995 01/01/1900 Alprostadil NDA NDA020379 41.1 ug/mL
Caverject ALPROSTADIL Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 07/06/1995 01/01/1900 Alprostadil NDA NDA020379 5.4 ug/mL
Caverject Impulse Alprostadil Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/11/2002 01/01/1900 Alprostadil NDA NDA021212 10 ug/.5mL
Caverject Impulse Alprostadil Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/11/2002 01/01/1900 Alprostadil NDA NDA021212 20 ug/.5mL
CEENU LOMUSTINE Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 12/15/2008 04/15/2016 Lomustine NDA NDA017588 10 mg/1
CEENU LOMUSTINE Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 12/15/2008 04/15/2016 Lomustine NDA NDA017588 40 mg/1
CELEBREX Celecoxib Capsule HUMAN PRESCRIPTION DRUG 10/02/1998 01/01/1900 Celecoxib NDA NDA020998 50 mg/1
CELEBREX Celecoxib Capsule HUMAN PRESCRIPTION DRUG 10/02/1998 01/01/1900 Celecoxib NDA NDA020998 100 mg/1
CELEBREX Celecoxib Capsule HUMAN PRESCRIPTION DRUG 10/02/1998 01/01/1900 Celecoxib NDA NDA020998 200 mg/1
CELEBREX Celecoxib Capsule HUMAN PRESCRIPTION DRUG 10/02/1998 01/01/1900 Celecoxib NDA NDA020998 400 mg/1
CellCept Mycophenolate Mofetil Capsule HUMAN PRESCRIPTION DRUG 05/03/1995 01/01/1900 Mycophenolate Mofetil NDA NDA050722 250 mg/1
CellCept Mycophenolate Mofetil Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/19/1997 01/01/1900 Mycophenolate Mofetil NDA NDA050723 500 mg/1
CellCept Mycophenolate Mofetil Powder, For Suspension HUMAN PRESCRIPTION DRUG 08/12/1998 01/01/1900 Mycophenolate Mofetil NDA NDA050759 200 mg/mL
CellCept Mycophenolate Mofetil hydrochloride Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 10/01/1998 01/01/1900 Mycophenolate Mofetil Hydrochloride NDA NDA050758 500 mg/20mL
Cesamet Nabilone Capsule HUMAN PRESCRIPTION DRUG 03/01/2010 01/01/1900 Nabilone NDA NDA018677 1 mg/1
CHILDRENS DIMETAPP COLD AND ALLERGY brompheniramine maleate, phenylephrine HCl Liquid HUMAN OTC DRUG 02/07/2007 01/01/1900 Brompheniramine Maleate; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 1; 2.5 mg/5mL; mg/5mL
CHILDRENS DIMETAPP COLD AND ALLERGY brompheniramine maleate, phenylephrine HCl Tablet, Chewable HUMAN OTC DRUG 09/27/2005 01/01/1900 Brompheniramine Maleate; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 1; 2.5 mg/1; mg/1
CHILDRENS DIMETAPP COLD AND COUGH brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl Liquid HUMAN OTC DRUG 05/23/2006 01/01/1900 Brompheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL
CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD chlorpheniramine maleate, dextromethorphan HBr Liquid HUMAN OTC DRUG 03/04/2005 01/01/1900 Chlorpheniramine Maleate; Dextromethorphan Hydrobromide OTC MONOGRAPH FINAL part341 1; 7.5 mg/mL; mg/5mL
Childrens Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride Liquid HUMAN OTC DRUG 07/01/2014 01/01/1900 Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 320; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, phenylephrine HCl Liquid HUMAN OTC DRUG 10/04/2010 01/01/1900 Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydr OTC MONOGRAPH NOT FINAL part343 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION diphenhydramine HCl, phenylephrine HCl Liquid HUMAN OTC DRUG 11/01/2007 01/01/1900 Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 6.25; 2.5 mg/5mL; mg/5mL
Childrens Robitussin Cough and Chest Congestion DM dextromethorphan hydrobromide, guaifenesin Liquid HUMAN OTC DRUG 07/01/2014 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin OTC MONOGRAPH FINAL part341 5; 100 mg/5mL; mg/5mL
Childrens Robitussin Cough and Cold CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE Liquid HUMAN OTC DRUG 09/01/2009 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING chlorpheniramine maleate, dextrometrorphan HBr Liquid HUMAN OTC DRUG 01/01/2004 01/01/1900 Chlorpheniramine Maleate; Dextromethorphan Hydrobromide OTC MONOGRAPH FINAL part341 1; 7.5 mg/5mL; mg/5mL
Childrens Robitussin Cough Long-Acting DEXTROMETHORPHAN HYDROBROMIDE Liquid HUMAN OTC DRUG 01/01/2004 01/01/1900 Dextromethorphan Hydrobromide OTC MONOGRAPH FINAL part341 7.5 mg/5mL
Childrens Robitussin Nighttime Cough Long-Acting DM chlorpheniramine maleate, dextromethorphan hyrdrobromide Liquid HUMAN OTC DRUG 07/01/2014 01/01/1900 Chlorpheniramine Maleate; Dextromethorphan Hydrobromide OTC MONOGRAPH FINAL part341 2; 15 mg/10mL; mg/10mL
Cialis Tadalafil Tablet, Film Coated HUMAN PRESCRIPTION DRUG 11/26/2003 01/01/1900 Tadalafil NDA NDA021368 5 mg/1
Cialis Tadalafil Tablet, Film Coated HUMAN PRESCRIPTION DRUG 11/26/2003 01/01/1900 Tadalafil NDA NDA021368 10 mg/1
Cialis Tadalafil Tablet, Film Coated HUMAN PRESCRIPTION DRUG 11/26/2003 01/01/1900 Tadalafil NDA NDA021368 20 mg/1
Cialis Tadalafil Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/07/2008 01/01/1900 Tadalafil NDA NDA021368 2.5 mg/1
Cilostazol Cilostazol Tablet HUMAN PRESCRIPTION DRUG 05/17/2005 01/01/1900 Cilostazol ANDA ANDA077024 50 mg/1
Cilostazol Cilostazol Tablet HUMAN PRESCRIPTION DRUG 01/05/2011 01/01/1900 Cilostazol ANDA ANDA077024 100 mg/1
Citalopram Citalopram Solution HUMAN PRESCRIPTION DRUG 05/25/2004 01/01/1900 Citalopram Hydrobromide ANDA ANDA065178 10 mg/5mL
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 03/11/1981 01/01/1900 Cefotaxime Sodium NDA NDA050547 500 mg/1
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 03/11/1981 01/01/1900 Cefotaxime Sodium NDA NDA050547 1 g/1
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 03/11/1981 01/01/1900 Cefotaxime Sodium NDA NDA050547 2 g/1
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 03/11/1981 01/01/1900 Cefotaxime Sodium NDA NDA050547 10 g/1
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 01/13/1987 01/01/1900 Cefotaxime Sodium ANDA ANDA062659 1 g/1
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 01/13/1987 01/01/1900 Cefotaxime Sodium ANDA ANDA062659 2 g/1
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 05/20/1985 01/01/1900 Cefotaxime Sodium NDA NDA050596 1 g/50mL
Claforan cefotaxime sodium Injection HUMAN PRESCRIPTION DRUG 05/20/1985 01/01/1900 Cefotaxime Sodium NDA NDA050596 2 g/50mL
Clarithromycin clarithromycin Tablet, Coated HUMAN PRESCRIPTION DRUG 11/22/2004 01/01/1900 Clarithromycin ANDA ANDA065178 250 mg/1
Clarithromycin clarithromycin Tablet, Coated HUMAN PRESCRIPTION DRUG 05/25/2004 01/01/1900 Clarithromycin ANDA ANDA065178 500 mg/1
Cleocin clindamycin phosphate Suppository HUMAN PRESCRIPTION DRUG 08/13/1999 01/01/1900 Clindamycin Phosphate NDA NDA050767 100 mg/1
Cleocin clindamycin phosphate Cream HUMAN PRESCRIPTION DRUG 08/11/1992 01/01/1900 Clindamycin Phosphate NDA NDA050680 20 mg/g
Cleocin Hydrochloride clindamycin hydrochloride Capsule HUMAN PRESCRIPTION DRUG 05/22/1970 01/01/1900 Clindamycin Hydrochloride NDA NDA050162 300 mg/1
Cleocin Hydrochloride clindamycin hydrochloride Capsule HUMAN PRESCRIPTION DRUG 05/22/1970 01/01/1900 Clindamycin Hydrochloride NDA NDA050162 150 mg/1
Cleocin Hydrochloride clindamycin hydrochloride Capsule HUMAN PRESCRIPTION DRUG 05/22/1970 01/01/1900 Clindamycin Hydrochloride NDA NDA050162 75 mg/1
Cleocin Pediatric clindamycin palmitate hydrochloride Granule, For Solution HUMAN PRESCRIPTION DRUG 04/17/1986 01/01/1900 Clindamycin Palmitate Hydrochloride ANDA ANDA062644 75 mg/5mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 10/02/1972 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 10/02/1972 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 04/10/2014 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 10/02/1972 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 04/10/2014 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 10/02/1972 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 10/16/1987 01/01/1900 Clindamycin Phosphate ANDA ANDA062803 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 08/30/1990 01/01/1900 Clindamycin Phosphate NDA NDA050639 12 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 08/30/1990 01/01/1900 Clindamycin Phosphate NDA NDA050639 6 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 08/30/1990 01/01/1900 Clindamycin Phosphate NDA NDA050639 18 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 10/16/1987 01/01/1900 Clindamycin Phosphate ANDA ANDA062803 150 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 09/26/2014 01/01/1900 Clindamycin Phosphate NDA NDA050639 18 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 09/26/2014 01/01/1900 Clindamycin Phosphate NDA NDA050639 12 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 09/26/2014 01/01/1900 Clindamycin Phosphate NDA NDA050639 6 mg/mL
Cleocin Phosphate clindamycin phosphate Injection, Solution HUMAN PRESCRIPTION DRUG 04/10/2014 01/01/1900 Clindamycin Phosphate NDA NDA050441 150 mg/mL
Cleocin T clindamycin phosphate Solution HUMAN PRESCRIPTION DRUG 06/20/1980 01/01/1900 Clindamycin Phosphate NDA NDA050537 10 mg/mL
Cleocin T clindamycin phosphate Lotion HUMAN PRESCRIPTION DRUG 05/31/1989 01/01/1900 Clindamycin Phosphate NDA NDA050600 10 mg/mL
Cleocin T clindamycin phosphate Gel HUMAN PRESCRIPTION DRUG 01/07/1987 01/01/1900 Clindamycin Phosphate NDA NDA050615 10 mg/g
Clolar clofarabine Injection HUMAN PRESCRIPTION DRUG 04/01/2013 01/01/1900 Clofarabine NDA NDA021673 1 mg/mL
Colestid Colestipol Hydrochloride Tablet HUMAN PRESCRIPTION DRUG 07/19/1994 01/01/1900 Colestipol Hydrochloride NDA NDA020222 1 g/1
Colestid Colestipol Hydrochloride Granule, For Suspension HUMAN PRESCRIPTION DRUG 04/04/1977 01/01/1900 Colestipol Hydrochloride NDA NDA017563 5 g/5g
COLYTE peg-3350 and electrolytes Powder, For Solution HUMAN PRESCRIPTION DRUG 08/05/2014 01/01/1900 Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium NDA NDA018983 240; 2.98; 6.72; 5.84; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L
COMBIGAN brimonidine tartrate, timolol maleate Solution/ Drops HUMAN PRESCRIPTION DRUG 11/14/2007 01/01/1900 Brimonidine Tartrate; Timolol Maleate NDA NDA021398 2; 5 mg/mL; mg/mL
COMVAX Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Va Injection, Suspension VACCINE 10/02/1996 01/01/1900 Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein BLA BLA103623 7.5; 5 ug/.5mL; ug/.5mL
Conray iothalamate meglumine Injection HUMAN PRESCRIPTION DRUG 10/14/2003 01/01/1900 Iothalamate Meglumine NDA NDA013295 600 mg/mL
Conray 30 Iothalamate Meglumine Injection HUMAN PRESCRIPTION DRUG 03/26/2012 01/01/1900 Iothalamate Meglumine NDA NDA016983 300 mg/mL
Conray 43 iothalamate meglumine Injection HUMAN PRESCRIPTION DRUG 10/11/2010 01/01/1900 Iothalamate Meglumine NDA NDA013295 430 mg/mL
Copegus Ribavirin Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/03/2002 01/01/1900 Ribavirin NDA NDA021511 200 mg/1
Cordarone amiodarone hydrochloride Tablet HUMAN PRESCRIPTION DRUG 12/01/1985 01/01/1900 Amiodarone Hydrochloride NDA NDA018972 200 mg/1
COREG carvedilol phosphate Capsule, Extended Release HUMAN PRESCRIPTION DRUG 02/09/2007 01/01/1900 Carvedilol Phosphate NDA NDA022012 10 mg/1
COREG carvedilol phosphate Capsule, Extended Release HUMAN PRESCRIPTION DRUG 02/06/2007 01/01/1900 Carvedilol Phosphate NDA NDA022012 20 mg/1
COREG carvedilol phosphate Capsule, Extended Release HUMAN PRESCRIPTION DRUG 02/14/2007 01/01/1900 Carvedilol Phosphate NDA NDA022012 40 mg/1
COREG carvedilol phosphate Capsule, Extended Release HUMAN PRESCRIPTION DRUG 02/20/2007 01/01/1900 Carvedilol Phosphate NDA NDA022012 80 mg/1
COREG carvedilol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/03/1997 01/01/1900 Carvedilol NDA NDA020297 3.125 mg/1
COREG carvedilol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/03/1997 01/01/1900 Carvedilol NDA NDA020297 6.25 mg/1
COREG carvedilol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/03/1997 01/01/1900 Carvedilol NDA NDA020297 12.5 mg/1
COREG carvedilol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/03/1997 01/01/1900 Carvedilol NDA NDA020297 25 mg/1
CORTEF hydrocortisone Tablet HUMAN PRESCRIPTION DRUG 12/15/1952 01/01/1900 Hydrocortisone NDA NDA008697 5 mg/1
CORTEF hydrocortisone Tablet HUMAN PRESCRIPTION DRUG 12/15/1952 01/01/1900 Hydrocortisone NDA NDA008697 10 mg/1
CORTEF hydrocortisone Tablet HUMAN PRESCRIPTION DRUG 12/15/1952 01/01/1900 Hydrocortisone NDA NDA008697 20 mg/1
Corvert IBUTILIDE FUMARATE Injection, Solution HUMAN PRESCRIPTION DRUG 12/28/1995 01/01/1900 Ibutilide Fumarate NDA NDA020491 0.1 mg/mL
Corvert ibutilide fumarate Injection, Solution HUMAN PRESCRIPTION DRUG 12/28/1995 01/01/1900 Ibutilide Fumarate NDA NDA020491 0.1 mg/mL
Corvert IBUTILIDE FUMARATE Injection, Solution HUMAN PRESCRIPTION DRUG 12/28/1995 01/01/1900 Ibutilide Fumarate NDA NDA020491 0.1 mg/mL
COSOPT dorzolamide hydrochloride and timolol maleate Solution HUMAN PRESCRIPTION DRUG 04/07/1998 01/01/1900 Dorzolamide Hydrochloride; Timolol Maleate NDA NDA020869 20; 5 mg/mL; mg/mL
COSOPT DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE Solution HUMAN PRESCRIPTION DRUG 02/01/2012 01/01/1900 Dorzolamide Hydrochloride; Timolol Maleate NDA NDA202667 20; 5 mg/mL; mg/mL
Covera-HS verapamil hydrochloride Tablet, Extended Release HUMAN PRESCRIPTION DRUG 02/26/1996 01/01/1900 Verapamil Hydrochloride NDA NDA020552 180 mg/1
Covera-HS verapamil hydrochloride Tablet, Extended Release HUMAN PRESCRIPTION DRUG 02/26/1996 01/01/1900 Verapamil Hydrochloride NDA NDA020552 240 mg/1
COZAAR losartan potassium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/14/1995 01/01/1900 Losartan Potassium NDA NDA020386 25 mg/1
COZAAR losartan potassium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/14/1995 01/01/1900 Losartan Potassium NDA NDA020386 50 mg/1
COZAAR losartan potassium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/14/1995 01/01/1900 Losartan Potassium NDA NDA020386 100 mg/1
Creon Pancrelipase Capsule, Delayed Release Pellets HUMAN PRESCRIPTION DRUG 03/14/2013 01/01/1900 Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease NDA NDA020725 180000; 36000; 114000 [USP'U]/1; [USP'U]/1; [USP'U]/1
Creon Pancrelipase Capsule, Delayed Release HUMAN PRESCRIPTION DRUG 04/30/2009 01/01/1900 Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease NDA NDA020725 15000; 3000; 9500 [USP'U]/1; [USP'U]/1; [USP'U]/1
Creon Pancrelipase Capsule, Delayed Release Pellets HUMAN PRESCRIPTION DRUG 04/30/2009 01/01/1900 Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease NDA NDA020725 30000; 6000; 19000 [USP'U]/1; [USP'U]/1; [USP'U]/1
Creon Pancrelipase Capsule, Delayed Release Pellets HUMAN PRESCRIPTION DRUG 04/30/2009 01/01/1900 Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease NDA NDA020725 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1
Creon Pancrelipase Capsule, Delayed Release Pellets HUMAN PRESCRIPTION DRUG 04/30/2009 01/01/1900 Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease NDA NDA020725 120000; 24000; 76000 [USP'U]/1; [USP'U]/1; [USP'U]/1
CRIXIVAN indinavir sulfate Capsule HUMAN PRESCRIPTION DRUG 03/13/1996 01/01/1900 Indinavir Sulfate NDA NDA020685 200 mg/1
CRIXIVAN indinavir sulfate Capsule HUMAN PRESCRIPTION DRUG 03/13/1996 01/01/1900 Indinavir Sulfate NDA NDA020685 400 mg/1
CYCLESSA desogestrel and ethinyl estradiol Kit HUMAN PRESCRIPTION DRUG 12/20/2000 01/01/1900 NDA NDA021090
Cyklokapron TRANEXAMIC ACID Injection, Solution HUMAN PRESCRIPTION DRUG 12/30/1986 01/01/1900 Tranexamic Acid NDA NDA019281 100 mg/mL
Cymbalta Duloxetine hydrochloride Capsule, Delayed Release HUMAN PRESCRIPTION DRUG 01/15/2010 01/01/1900 Duloxetine Hydrochloride NDA NDA021427 60 mg/1
Cymbalta Duloxetine hydrochloride Capsule, Delayed Release HUMAN PRESCRIPTION DRUG 08/24/2004 01/01/1900 Duloxetine Hydrochloride NDA NDA021427 20 mg/1
Cymbalta Duloxetine hydrochloride Capsule, Delayed Release HUMAN PRESCRIPTION DRUG 08/24/2004 01/01/1900 Duloxetine Hydrochloride NDA NDA021427 30 mg/1
CYRAMZA ramucirumab Solution HUMAN PRESCRIPTION DRUG 04/21/2014 01/01/1900 Ramucirumab BLA BLA125477 10 mg/mL
CYRAMZA ramucirumab Solution HUMAN PRESCRIPTION DRUG 04/21/2014 01/01/1900 Ramucirumab BLA BLA125477 10 mg/mL
Cysto-Conray II Iothalamate meglumine Injection HUMAN PRESCRIPTION DRUG 10/08/2010 01/01/1900 Iothalamate Meglumine NDA NDA017057 172 mg/mL
Cytotec misoprostol Tablet HUMAN PRESCRIPTION DRUG 12/27/1986 01/01/1900 Misoprostol NDA NDA019268 100 ug/1
Cytotec misoprostol Tablet HUMAN PRESCRIPTION DRUG 12/27/1986 01/01/1900 Misoprostol NDA NDA019268 200 ug/1
Cytovene ganciclovir sodium Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/23/1989 01/01/1900 Ganciclovir Sodium NDA NDA019661 500 mg/10mL
Daypro OXAPROZIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/29/1992 01/01/1900 Oxaprozin NDA NDA018841 600 mg/1
Demadex Torsemide Tablet HUMAN PRESCRIPTION DRUG 01/01/2015 01/01/1900 Torsemide NDA NDA020136 5 mg/1
Demadex Torsemide Tablet HUMAN PRESCRIPTION DRUG 01/01/2015 01/01/1900 Torsemide NDA NDA020136 10 mg/1
Demadex Torsemide Tablet HUMAN PRESCRIPTION DRUG 02/20/2009 01/01/1900 Torsemide NDA NDA020136 100 mg/1
Demadex Torsemide Tablet HUMAN PRESCRIPTION DRUG 02/20/2009 01/01/1900 Torsemide NDA NDA020136 5 mg/1
Demadex Torsemide Tablet HUMAN PRESCRIPTION DRUG 02/20/2009 01/01/1900 Torsemide NDA NDA020136 10 mg/1
Demadex Torsemide Tablet HUMAN PRESCRIPTION DRUG 02/20/2009 01/01/1900 Torsemide NDA NDA020136 20 mg/1
Demerol Meperidine Hydrochloride Tablet HUMAN PRESCRIPTION DRUG 11/10/1942 01/01/1900 Meperidine Hydrochloride NDA NDA005010 50 mg/1
Demerol Meperidine Hydrochloride Tablet HUMAN PRESCRIPTION DRUG 04/01/2013 01/01/1900 Meperidine Hydrochloride NDA NDA005010 50 mg/1
Demerol Meperidine Hydrochloride Tablet HUMAN PRESCRIPTION DRUG 11/10/1942 01/01/1900 Meperidine Hydrochloride NDA NDA005010 100 mg/1
Demerol Meperidine Hydrochloride Tablet HUMAN PRESCRIPTION DRUG 05/21/2012 01/01/1900 Meperidine Hydrochloride NDA NDA005010 100 mg/1
Depen Penicillamine Tablet HUMAN PRESCRIPTION DRUG 11/30/1978 01/01/1900 Penicillamine NDA NDA019854 250 mg/1
Depo-Estradiol estradiol cypionate Injection HUMAN PRESCRIPTION DRUG 08/15/1979 01/01/1900 Estradiol Cypionate ANDA ANDA085470 5 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 20 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 40 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 40 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 80 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 80 mg/mL
Depo-Medrol METHYLPREDNISOLONE ACETATE Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 40 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 40 mg/mL
Depo-Medrol METHYLPREDNISOLONE ACETATE Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 80 mg/mL
Depo-Medrol methylprednisolone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/28/1959 01/01/1900 Methylprednisolone Acetate NDA NDA011757 80 mg/mL
Depo-Provera medroxyprogesterone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 10/29/1992 01/01/1900 Medroxyprogesterone Acetate NDA NDA020246 150 mg/mL
Depo-Provera medroxyprogesterone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 10/29/1992 01/01/1900 Medroxyprogesterone Acetate NDA NDA020246 150 mg/mL
Depo-Provera medroxyprogesterone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 11/01/1960 01/01/1900 Medroxyprogesterone Acetate NDA NDA012541 400 mg/mL
Depo-SubQ Provera medroxyprogesterone acetate Injection, Suspension HUMAN PRESCRIPTION DRUG 05/02/2005 01/01/1900 Medroxyprogesterone Acetate NDA NDA021583 104 mg/.65mL
Depo-Testosterone testosterone cypionate Injection, Solution HUMAN PRESCRIPTION DRUG 03/31/2014 01/01/1900 Testosterone Cypionate ANDA ANDA085635 200 mg/mL
Depo-Testosterone testosterone cypionate Injection, Solution HUMAN PRESCRIPTION DRUG 07/25/1979 01/01/1900 Testosterone Cypionate ANDA ANDA085635 200 mg/mL
Depo-Testosterone testosterone cypionate Injection, Solution HUMAN PRESCRIPTION DRUG 07/25/1979 01/01/1900 Testosterone Cypionate ANDA ANDA085635 100 mg/mL
Depo-Testosterone testosterone cypionate Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2014 01/01/1900 Testosterone Cypionate ANDA ANDA085635 100 mg/mL
Depo-Testosterone testosterone cypionate Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2014 01/01/1900 Testosterone Cypionate ANDA ANDA085635 200 mg/mL
Desogen desogestrel and ethinyl estradiol Kit HUMAN PRESCRIPTION DRUG 06/10/2010 01/01/1900 NDA NDA020071
Detrol tolterodine tartrate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/25/1998 01/01/1900 Tolterodine Tartrate NDA NDA020771 1 mg/1
Detrol tolterodine tartrate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/25/1998 01/01/1900 Tolterodine Tartrate NDA NDA020771 2 mg/1
Detrol LA tolterodine tartrate Capsule, Extended Release HUMAN PRESCRIPTION DRUG 02/22/2000 01/01/1900 Tolterodine Tartrate NDA NDA021228 2 mg/1
Detrol LA tolterodine tartrate Capsule, Extended Release HUMAN PRESCRIPTION DRUG 02/22/2000 01/01/1900 Tolterodine Tartrate NDA NDA021228 4 mg/1
DiaBeta glyburide Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Glyburide NDA NDA017532 2.5 mg/1
DiaBeta glyburide Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Glyburide NDA NDA017532 5 mg/1
DiaBeta glyburide Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Glyburide NDA NDA017532 1.25 mg/1
DIDREX benzphetamine hydrochloride Tablet HUMAN PRESCRIPTION DRUG 10/26/1960 01/01/1900 Benzphetamine Hydrochloride NDA NDA012427 50 mg/1
Diflucan fluconazole Tablet HUMAN PRESCRIPTION DRUG 01/29/1990 01/01/1900 Fluconazole NDA NDA019949 50 mg/1
Diflucan fluconazole Tablet HUMAN PRESCRIPTION DRUG 01/29/1990 01/01/1900 Fluconazole NDA NDA019949 100 mg/1
Diflucan fluconazole Tablet HUMAN PRESCRIPTION DRUG 01/29/1990 01/01/1900 Fluconazole NDA NDA019949 200 mg/1
Diflucan fluconazole Powder, For Suspension HUMAN PRESCRIPTION DRUG 12/23/1993 01/01/1900 Fluconazole NDA NDA020090 350 mg/35mL
Diflucan fluconazole Powder, For Suspension HUMAN PRESCRIPTION DRUG 12/23/1993 01/01/1900 Fluconazole NDA NDA020090 1400 mg/35mL
Diflucan fluconazole Tablet HUMAN PRESCRIPTION DRUG 01/29/1990 01/01/1900 Fluconazole NDA NDA019949 150 mg/1
Digoxin Digoxin Solution HUMAN PRESCRIPTION DRUG 08/26/2004 01/01/1900 Digoxin NDA NDA021648 0.05 mg/mL
Dipentum olsalazine sodium Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 05/15/2015 01/01/1900 Olsalazine Sodium NDA NDA019715 250 mg/1
DRISDOL Ergocalciferol Capsule, Liquid Filled HUMAN PRESCRIPTION DRUG 11/11/1974 01/01/1900 Ergocalciferol NDA NDA003444 1.25 mg/1
DROXIA HYDROXYUREA Capsule HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Hydroxyurea NDA NDA016295 200 mg/1
DROXIA HYDROXYUREA Capsule HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Hydroxyurea NDA NDA016295 300 mg/1
DROXIA HYDROXYUREA Capsule HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Hydroxyurea NDA NDA016295 400 mg/1
Duavee conjugated estrogens/bazedoxifene Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/03/2013 01/01/1900 Bazedoxifene Acetate; Estrogens, Conjugated NDA NDA022247 20; .45 mg/1; mg/1
DYAZIDE hydrochlorothiazide and triamterene Capsule HUMAN PRESCRIPTION DRUG 03/30/1994 01/01/1900 Hydrochlorothiazide; Triamterene NDA NDA016042 25; 37.5 mg/1; mg/1
DYMISTA Azelastine Hydrochloride and Fluticasone Propionate Spray, Metered HUMAN PRESCRIPTION DRUG 05/01/2012 01/01/1900 Azelastine Hydrochloride; Fluticasone Propionate NDA NDA202236 137; 50 ug/1; ug/1
EC-Naprosyn naproxen Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 10/14/1994 01/01/1900 Naproxen NDA NDA020067 375 mg/1
EC-Naprosyn naproxen Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 10/14/1994 01/01/1900 Naproxen NDA NDA020067 500 mg/1
Edluar Zolpidem Tartrate Tablet HUMAN PRESCRIPTION DRUG 07/24/2009 01/01/1900 Zolpidem Tartrate NDA NDA021997 10 mg/1
Edluar Zolpidem Tartrate Tablet HUMAN PRESCRIPTION DRUG 07/24/2009 01/01/1900 Zolpidem Tartrate NDA NDA021997 5 mg/1
Effexor VENLAFAXINE HYDROCHLORIDE Capsule, Extended Release HUMAN PRESCRIPTION DRUG 11/01/1997 01/01/1900 Venlafaxine Hydrochloride NDA NDA020699 75 mg/1
Effexor VENLAFAXINE HYDROCHLORIDE Capsule, Extended Release HUMAN PRESCRIPTION DRUG 11/01/1997 01/01/1900 Venlafaxine Hydrochloride NDA NDA020699 150 mg/1
Effexor VENLAFAXINE HYDROCHLORIDE Capsule, Extended Release HUMAN PRESCRIPTION DRUG 11/01/1997 01/01/1900 Venlafaxine Hydrochloride NDA NDA020699 37.5 mg/1
Effient Prasugrel hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/01/2012 01/01/1900 Prasugrel Hydrochloride NDA NDA022307 5 mg/1
Effient Prasugrel hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/01/2012 01/01/1900 Prasugrel Hydrochloride NDA NDA022307 10 mg/1
ELESTAT epinastine hydrochloride Solution/ Drops HUMAN PRESCRIPTION DRUG 01/19/2004 01/01/1900 Epinastine Hydrochloride NDA NDA021565 0.5 mg/mL
ELESTRIN estradiol gel 0.06% Gel, Metered HUMAN PRESCRIPTION DRUG 06/02/2014 01/01/1900 Estradiol NDA NDA021813 0.52 mg/g
ELESTRIN estradiol gel 0.06% Gel, Metered HUMAN PRESCRIPTION DRUG 06/02/2014 01/01/1900 Estradiol NDA NDA021813 0.52 mg/g
ELIGARD leuprolide acetate Kit HUMAN PRESCRIPTION DRUG 01/23/2002 01/01/1900 NDA NDA021379
ELIGARD leuprolide acetate Kit HUMAN PRESCRIPTION DRUG 01/23/2002 01/01/1900 NDA NDA021731
ELIGARD leuprolide acetate Kit HUMAN PRESCRIPTION DRUG 01/23/2002 01/01/1900 NDA NDA021488
ELIGARD leuprolide acetate Kit HUMAN PRESCRIPTION DRUG 01/23/2002 01/01/1900 NDA NDA021343
ELIQUIS apixaban Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/28/2012 01/01/1900 Apixaban NDA NDA202155 2.5 mg/1
ELIQUIS apixaban Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/28/2012 01/01/1900 Apixaban NDA NDA202155 5 mg/1
Elitek rasburicase Kit HUMAN PRESCRIPTION DRUG 07/12/2002 01/01/1900 BLA BLA103946
Elitek rasburicase Kit HUMAN PRESCRIPTION DRUG 06/01/2006 01/01/1900 BLA BLA103940
Ellence epirubicin hydrochloride Injection, Solution HUMAN PRESCRIPTION DRUG 09/15/1999 01/01/1900 Epirubicin Hydrochloride NDA NDA050778 2 mg/mL
Ellence epirubicin hydrochloride Injection, Solution HUMAN PRESCRIPTION DRUG 09/15/1999 01/01/1900 Epirubicin Hydrochloride NDA NDA050778 2 mg/mL
ELOXATIN oxaliplatin Injection, Solution, Concentrate HUMAN PRESCRIPTION DRUG 06/02/2006 01/01/1900 Oxaliplatin NDA NDA021759 5 mg/mL
ELOXATIN oxaliplatin Injection, Solution, Concentrate HUMAN PRESCRIPTION DRUG 06/02/2006 01/01/1900 Oxaliplatin NDA NDA021759 5 mg/mL
Emcyt estramustine phosphate sodium Capsule HUMAN PRESCRIPTION DRUG 01/01/1992 01/01/1900 Estramustine Phosphate Sodium NDA NDA018045 140 mg/1
EMEND aprepitant Capsule HUMAN PRESCRIPTION DRUG 03/26/2003 01/01/1900 Aprepitant NDA NDA021549 80 mg/1
EMEND aprepitant Capsule HUMAN PRESCRIPTION DRUG 03/26/2003 01/01/1900 Aprepitant NDA NDA021549 125 mg/1
EMEND aprepitant Capsule HUMAN PRESCRIPTION DRUG 03/26/2003 01/01/1900 Aprepitant NDA NDA021549 40 mg/1
EMEND aprepitant Kit HUMAN PRESCRIPTION DRUG 03/26/2003 01/01/1900 NDA NDA021549
EMEND FOSAPREPITANT DIMEGLUMINE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/25/2008 01/01/1900 Fosaprepitant Dimeglumine NDA NDA022023 115 mg/5mL
EMEND FOSAPREPITANT DIMEGLUMINE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/25/2008 01/01/1900 Fosaprepitant Dimeglumine NDA NDA022023 150 mg/5mL
EPIFOAM pramoxine hydrochloride and hydrocortisone acetate Aerosol, Foam HUMAN PRESCRIPTION DRUG 08/25/2014 01/01/1900 Hydrocortisone Acetate; Pramoxine Hydrochloride ANDA ANDA086457 100; 100 mg/10g; mg/10g
ERAXIS ANIDULAFUNGIN Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 02/17/2006 01/01/1900 Anidulafungin NDA NDA021632 50 mg/15mL
ERAXIS ANIDULAFUNGIN Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 02/17/2006 01/01/1900 Anidulafungin NDA NDA021632 100 mg/30mL
Estring estradiol Ring HUMAN PRESCRIPTION DRUG 04/26/1996 01/01/1900 Estradiol NDA NDA020472 2 mg/1
ETOPOPHOS etoposide phosphate Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Etoposide Phosphate NDA NDA020457 100 mg/1
Evista Raloxifene hydrochloride Tablet HUMAN PRESCRIPTION DRUG 01/06/1998 01/01/1900 Raloxifene Hydrochloride NDA NDA020815 60 mg/1
EVOTAZ atazanavir and cobicistat Tablet HUMAN PRESCRIPTION DRUG 01/29/2015 01/01/1900 Atazanavir Sulfate; Cobicistat NDA NDA206353 300; 150 mg/1; mg/1
Exemestane Exemestane Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/01/2011 01/01/1900 Exemestane ANDA ANDA077431 25 mg/1
FARXIGA DAPAGLIFLOZIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/08/2014 04/30/2017 Dapagliflozin Propanediol NDA NDA202293 5 mg/1
FARXIGA DAPAGLIFLOZIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/08/2014 08/31/2017 Dapagliflozin Propanediol NDA NDA202293 10 mg/1
Felbatol felbamate Tablet HUMAN PRESCRIPTION DRUG 07/29/1993 01/01/1900 Felbamate NDA NDA020189 400 mg/1
Felbatol felbamate Tablet HUMAN PRESCRIPTION DRUG 07/29/1993 01/01/1900 Felbamate NDA NDA020189 600 mg/1
Felbatol felbamate Suspension HUMAN PRESCRIPTION DRUG 07/29/1993 01/01/1900 Felbamate NDA NDA020189 600 mg/5mL
Ferrlecit sodium ferric gluconate complex Injection HUMAN PRESCRIPTION DRUG 03/01/2011 01/01/1900 Sodium Ferric Gluconate Complex NDA NDA020955 12.5 mg/mL
Ferrlecit sodium ferric gluconate complex Injection HUMAN PRESCRIPTION DRUG 07/07/2014 01/01/1900 Sodium Ferric Gluconate Complex NDA NDA020955 12.5 mg/mL
FIBERCON CALCIUM POLYCARBOPHIL Tablet HUMAN OTC DRUG 01/05/2004 01/01/1900 Calcium Polycarbophil OTC MONOGRAPH NOT FINAL part334 625 mg/1
Flagyl metronidazole Capsule HUMAN PRESCRIPTION DRUG 05/03/1995 01/01/1900 Metronidazole NDA NDA020334 375 mg/1
Flagyl Metronidazole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 07/18/1963 01/01/1900 Metronidazole NDA NDA012623 500 mg/1
Flagyl Metronidazole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 07/18/1963 01/01/1900 Metronidazole NDA NDA012623 250 mg/1
Flagyl ER Metronidazole Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 11/26/1997 01/01/1900 Metronidazole NDA NDA020868 750 mg/1
Flavored Colestid Colestipol Hydrochloride Granule, For Suspension HUMAN PRESCRIPTION DRUG 04/04/1977 01/01/1900 Colestipol Hydrochloride NDA NDA017563 5 g/7.5g
Flecainide Acetate flecainide acetate Tablet HUMAN PRESCRIPTION DRUG 01/14/2003 01/01/1900 Flecainide Acetate ANDA ANDA076278 50 mg/1
Flecainide Acetate flecainide acetate Tablet HUMAN PRESCRIPTION DRUG 01/14/2003 01/01/1900 Flecainide Acetate ANDA ANDA076278 100 mg/1
Flecainide Acetate flecainide acetate Tablet HUMAN PRESCRIPTION DRUG 01/14/2003 01/01/1900 Flecainide Acetate ANDA ANDA076278 150 mg/1
Fluconazole Fluconazole Powder, For Suspension HUMAN PRESCRIPTION DRUG 07/29/2004 01/01/1900 Fluconazole ANDA ANDA076246 10 mg/mL
Fluconazole Fluconazole Powder, For Suspension HUMAN PRESCRIPTION DRUG 07/29/2004 01/01/1900 Fluconazole ANDA ANDA076246 40 mg/mL
FML fluorometholone Ointment HUMAN PRESCRIPTION DRUG 12/09/1985 01/01/1900 Fluorometholone NDA NDA017760 1 mg/g
Follistim AQ follitropin Injection, Solution HUMAN PRESCRIPTION DRUG 03/24/2004 01/01/1900 Follitropin NDA NDA021211 650 [iU]/.78mL
Follistim AQ follitropin Injection, Solution HUMAN PRESCRIPTION DRUG 03/24/2004 01/01/1900 Follitropin NDA NDA021211 975 [iU]/1.17mL
Follistim AQ follitropin Injection, Solution HUMAN PRESCRIPTION DRUG 06/28/2010 01/01/1900 Follitropin NDA NDA021273 75 [iU]/.5mL
Follistim AQ follitropin Injection, Solution HUMAN PRESCRIPTION DRUG 06/28/2010 01/01/1900 Follitropin NDA NDA021273 150 [iU]/.5mL
Follistim AQ follitropin Injection, Solution HUMAN PRESCRIPTION DRUG 03/24/2004 01/01/1900 Follitropin NDA NDA021211 350 [iU]/.42mL
Forteo Teriparatide Injection, Solution HUMAN PRESCRIPTION DRUG 10/01/2008 01/01/1900 Teriparatide NDA NDA021318 250 ug/mL
FOSAMAX alendronate sodium Tablet HUMAN PRESCRIPTION DRUG 09/29/1995 01/01/1900 Alendronate Sodium NDA NDA020560 70 mg/1
FOSAMAX PLUS D ALENDRONATE SODIUM and CHOLECALCIFEROL Tablet HUMAN PRESCRIPTION DRUG 04/07/2005 01/01/1900 Alendronate Sodium; Cholecalciferol NDA NDA021762 70; 5600 mg/1; [iU]/1
FOSAMAX PLUS D ALENDRONATE SODIUM and CHOLECALCIFEROL Tablet HUMAN PRESCRIPTION DRUG 04/07/2005 01/01/1900 Alendronate Sodium; Cholecalciferol NDA NDA021762 70; 2800 mg/1; [iU]/1
FUZEON Enfuvirtide Kit HUMAN PRESCRIPTION DRUG 04/10/2012 01/01/1900 NDA NDA021481
GALLIUM CITRATE GA-67 gallium citrate ga-67 Injection, Solution HUMAN PRESCRIPTION DRUG 02/21/2008 01/01/1900 Gallium Chloride Ga-67 NDA NDA018058 2 mCi/mL
Ganirelix Acetate Ganirelix Acetate Injection, Solution HUMAN PRESCRIPTION DRUG 07/29/1999 01/01/1900 Ganirelix Acetate NDA NDA021057 250 ug/.5mL
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Injection, Suspension VACCINE 06/08/2006 01/01/1900 Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Ca BLA BLA125126 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Injection, Suspension VACCINE 06/08/2006 01/01/1900 Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Ca BLA BLA125126 40; 40; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant Injection, Suspension VACCINE 12/10/2014 01/01/1900 Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Ca BLA BLA125508 40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant Injection, Suspension VACCINE 12/10/2014 01/01/1900 Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Ca BLA BLA125508 40; 60; 40; 20; 20; 20; 20; 20; 30 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Gastrocrom cromolyn sodium Liquid HUMAN PRESCRIPTION DRUG 05/01/2015 01/01/1900 Cromolyn Sodium NDA NDA020479 20 mg/mL
Gemzar Gemcitabine hydrochloride Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 05/22/1996 01/01/1900 Gemcitabine Hydrochloride NDA NDA020509 200 mg/5mL
Gemzar Gemcitabine hydrochloride Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 05/22/1996 01/01/1900 Gemcitabine Hydrochloride NDA NDA020509 1 g/25mL
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
GENOTROPIN somatropin Kit HUMAN PRESCRIPTION DRUG 12/20/1995 01/01/1900 NDA NDA020280
Geodon ziprasidone mesylate Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 12/23/2003 01/01/1900 Ziprasidone Mesylate NDA NDA020919 20 mg/mL
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 02/05/2001 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 20 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 02/05/2001 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 40 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 02/05/2001 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 60 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 02/05/2001 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 80 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 11/01/2013 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 20 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 11/01/2013 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 40 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 11/01/2013 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 60 mg/1
Geodon ziprasidone hydrochloride Capsule HUMAN PRESCRIPTION DRUG 11/01/2013 01/01/1900 Ziprasidone Hydrochloride NDA NDA020825 80 mg/1
Glucagon glucagon Kit HUMAN PRESCRIPTION DRUG 03/01/1999 01/01/1900 NDA NDA020928
Glucotrol glipizide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 04/26/1994 01/01/1900 Glipizide NDA NDA020329 5 mg/1
Glucotrol glipizide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 04/10/1999 01/01/1900 Glipizide NDA NDA020329 10 mg/1
Glucotrol glipizide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 07/15/2013 01/01/1900 Glipizide NDA NDA020329 2.5 mg/1
Glucotrol glipizide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 10/01/2013 01/01/1900 Glipizide NDA NDA020329 5 mg/1
Glucotrol glipizide Tablet, Extended Release HUMAN PRESCRIPTION DRUG 05/09/2013 01/01/1900 Glipizide NDA NDA020329 10 mg/1
Glucotrol glipizide Tablet HUMAN PRESCRIPTION DRUG 05/08/1984 01/01/1900 Glipizide NDA NDA017783 5 mg/1
Glucotrol glipizide Tablet HUMAN PRESCRIPTION DRUG 05/08/1984 01/01/1900 Glipizide NDA NDA017783 10 mg/1
Glynase glyburide Tablet HUMAN PRESCRIPTION DRUG 03/04/1992 01/01/1900 Glyburide NDA NDA020051 6 mg/1
Glynase glyburide Tablet HUMAN PRESCRIPTION DRUG 03/04/1992 01/01/1900 Glyburide NDA NDA020051 3 mg/1
Glynase glyburide Tablet HUMAN PRESCRIPTION DRUG 03/04/1992 01/01/1900 Glyburide NDA NDA020051 1.5 mg/1
Glyset miglitol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/18/1996 01/01/1900 Miglitol NDA NDA020682 25 mg/1
Glyset miglitol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/18/1996 01/01/1900 Miglitol NDA NDA020682 50 mg/1
Glyset miglitol Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/18/1996 01/01/1900 Miglitol NDA NDA020682 100 mg/1
GRASTEK Timothy Grass Pollen Allergen Extract Tablet STANDARDIZED ALLERGENIC 04/11/2014 01/01/1900 Phleum Pratense Pollen BLA BLA125473 2800 [BAU]/1
Halcion triazolam Tablet HUMAN PRESCRIPTION DRUG 11/15/1982 01/01/1900 Triazolam NDA NDA017892 0.25 mg/1
HALOG Halcinonide Solution HUMAN PRESCRIPTION DRUG 01/01/2009 01/01/1900 Halcinonide NDA NDA017823 1 mg/mL
Helixate FS Antihemophilic Factor, Recombinant Kit PLASMA DERIVATIVE 08/18/2000 01/01/1900 BLA BLA103332
Helixate FS Antihemophilic Factor, Recombinant Kit PLASMA DERIVATIVE 08/18/2000 01/01/1900 BLA BLA103332
Helixate FS Antihemophilic Factor, Recombinant Kit PLASMA DERIVATIVE 08/18/2000 01/01/1900 BLA BLA103332
Helixate FS Antihemophilic Factor, Recombinant Kit PLASMA DERIVATIVE 01/16/2008 01/01/1900 BLA BLA103332
Helixate FS Antihemophilic Factor, Recombinant Kit PLASMA DERIVATIVE 07/31/2009 01/01/1900 BLA BLA103332
Hemabate carboprost tromethamine Injection, Solution HUMAN PRESCRIPTION DRUG 01/09/1979 01/01/1900 Carboprost Tromethamine NDA NDA017989 250 ug/mL
Hexabrix IOXAGLATE MEGLUMINE and IOXAGLATE SODIUM Injection HUMAN PRESCRIPTION DRUG 07/26/1985 01/01/1900 Ioxaglate Meglumine; Ioxaglate Sodium NDA NDA018905 393; 196 mg/mL; mg/mL
Humalog Insulin lispro Injection, Suspension HUMAN PRESCRIPTION DRUG 01/16/2008 01/01/1900 Insulin Lispro NDA NDA021017 100 [iU]/mL
Humalog Insulin lispro Injection, Suspension HUMAN PRESCRIPTION DRUG 02/07/2006 01/01/1900 Insulin Lispro NDA NDA021018 100 [iU]/mL
Humalog Insulin lispro Injection, Solution HUMAN PRESCRIPTION DRUG 01/16/2008 01/01/1900 Insulin Lispro NDA NDA020563 100 [iU]/mL
Humalog Insulin lispro Injection, Solution HUMAN PRESCRIPTION DRUG 05/26/2015 01/01/1900 Insulin Lispro NDA NDA205747 200 [iU]/mL
Humalog Insulin lispro Injection, Solution HUMAN PRESCRIPTION DRUG 07/24/1996 01/01/1900 Insulin Lispro NDA NDA020563 100 [iU]/mL
Humalog Insulin lispro Injection, Suspension HUMAN PRESCRIPTION DRUG 12/22/1999 01/01/1900 Insulin Lispro NDA NDA021017 100 [iU]/mL
Humalog Insulin lispro Injection, Suspension HUMAN PRESCRIPTION DRUG 02/07/2006 01/01/1900 Insulin Lispro NDA NDA021018 100 [iU]/mL
Humalog Insulin lispro Injection, Solution HUMAN PRESCRIPTION DRUG 02/20/1998 01/01/1900 Insulin Lispro NDA NDA020563 100 [iU]/mL
HUMATROPE Somatropin Kit HUMAN PRESCRIPTION DRUG 01/27/2006 01/01/1900 NDA NDA019640
HUMATROPE Somatropin Kit HUMAN PRESCRIPTION DRUG 01/27/2006 01/01/1900 NDA NDA019640
HUMATROPE Somatropin Kit HUMAN PRESCRIPTION DRUG 01/27/2006 01/01/1900 NDA NDA019640
HUMATROPE Somatropin Kit HUMAN PRESCRIPTION DRUG 04/01/1987 01/01/1900 NDA NDA019640
Humulin Insulin human Injection, Suspension HUMAN OTC DRUG 11/07/2013 01/01/1900 Insulin Human NDA NDA019717 100 [iU]/mL
Humulin Insulin human Injection, Suspension HUMAN OTC DRUG 11/07/2013 01/01/1900 Insulin Human NDA NDA018781 100 [iU]/mL
Humulin Insulin human Injection, Solution HUMAN PRESCRIPTION DRUG 01/06/1997 01/01/1900 Insulin Human NDA NDA018780 500 [iU]/mL
Humulin Insulin human Injection, Suspension HUMAN OTC DRUG 06/26/1989 01/01/1900 Insulin Human NDA NDA019717 100 [iU]/mL
Humulin Insulin human Injection, Suspension HUMAN OTC DRUG 02/01/1999 10/31/2015 Insulin Human NDA NDA018781 100 [iU]/mL
Humulin Insulin human Injection, Suspension HUMAN OTC DRUG 02/01/1999 10/31/2015 Insulin Human NDA NDA019717 100 [iU]/mL
Humulin Insulin human Injection, Solution HUMAN OTC DRUG 06/27/1983 01/01/1900 Insulin Human NDA NDA018780 100 [iU]/mL
Humulin Insulin human Injection, Suspension HUMAN OTC DRUG 06/27/1983 01/01/1900 Insulin Human NDA NDA018781 100 [iU]/mL
HYCAMTIN topotecan hydrochloride Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/07/1996 01/01/1900 Topotecan Hydrochloride NDA NDA020671 4 mg/4mL
HYCAMTIN topotecan hydrochloride Capsule HUMAN PRESCRIPTION DRUG 09/16/2008 01/01/1900 Topotecan Hydrochloride NDA NDA020981 0.25 mg/1
HYCAMTIN topotecan hydrochloride Capsule HUMAN PRESCRIPTION DRUG 09/16/2008 01/01/1900 Topotecan Hydrochloride NDA NDA020981 1 mg/1
HYDREA HYDROXYUREA Capsule HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Hydroxyurea NDA NDA016295 500 mg/1
HYZAAR losartan potassium and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/28/1995 01/01/1900 Hydrochlorothiazide; Losartan Potassium NDA NDA020387 12.5; 50 mg/1; mg/1
HYZAAR losartan potassium and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/28/1995 01/01/1900 Hydrochlorothiazide; Losartan Potassium NDA NDA020387 12.5; 100 mg/1; mg/1
HYZAAR losartan potassium and hydrochlorothiazide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/28/1995 01/01/1900 Hydrochlorothiazide; Losartan Potassium NDA NDA020387 25; 100 mg/1; mg/1
Idamycin PFS idarubicin hydrochloride Solution HUMAN PRESCRIPTION DRUG 02/17/1997 01/01/1900 Idarubicin Hydrochloride NDA NDA050734 1 mg/mL
Idamycin PFS idarubicin hydrochloride Solution HUMAN PRESCRIPTION DRUG 02/17/1997 01/01/1900 Idarubicin Hydrochloride NDA NDA050734 1 mg/mL
Idamycin PFS idarubicin hydrochloride Solution HUMAN PRESCRIPTION DRUG 02/17/1997 01/01/1900 Idarubicin Hydrochloride NDA NDA050734 1 mg/mL
IMPLANON etonogestrel Implant HUMAN PRESCRIPTION DRUG 09/06/2011 01/01/1900 Etonogestrel NDA NDA021529 68 mg/1
INDIUM IN 111 CHLORIDE indium in 111 chloride Solution HUMAN PRESCRIPTION DRUG 12/07/2007 01/01/1900 Indium In-111 Chloride NDA NDA019841 10 mCi/mL
Inspra eplerenone Tablet, Film Coated HUMAN PRESCRIPTION DRUG 09/27/2002 01/01/1900 Eplerenone NDA NDA021437 25 mg/1
Inspra eplerenone Tablet, Film Coated HUMAN PRESCRIPTION DRUG 09/27/2002 01/01/1900 Eplerenone NDA NDA021437 50 mg/1
INVANZ ertapenem sodium Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 11/21/2001 01/01/1900 Ertapenem Sodium NDA NDA021337 1 g/1
INVANZ ertapenem sodium Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 11/21/2001 01/01/1900 Ertapenem Sodium NDA NDA021337 1 g/1
Invirase saquinavir mesylate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/17/2004 01/01/1900 Saquinavir Mesylate NDA NDA021785 500 mg/1
Invirase saquinavir mesylate Capsule HUMAN PRESCRIPTION DRUG 12/06/1995 01/01/1900 Saquinavir Mesylate NDA NDA020628 200 mg/1
Ipratropium Bromide Ipratropium Bromide Spray HUMAN PRESCRIPTION DRUG 11/05/2003 01/01/1900 Ipratropium Bromide ANDA ANDA076664 21 ug/1
Ipratropium Bromide Ipratropium Bromide Spray HUMAN PRESCRIPTION DRUG 11/15/2003 01/01/1900 Ipratropium Bromide ANDA ANDA076598 42 ug/1
ISENTRESS RALTEGRAVIR Granule, For Suspension HUMAN PRESCRIPTION DRUG 12/20/2013 01/01/1900 Raltegravir Potassium NDA NDA205786 100 mg/1
ISENTRESS RALTEGRAVIR Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/12/2007 01/01/1900 Raltegravir Potassium NDA NDA022145 400 mg/1
ISENTRESS RALTEGRAVIR Tablet, Chewable HUMAN PRESCRIPTION DRUG 12/21/2011 01/01/1900 Raltegravir Potassium NDA NDA203045 25 mg/1
ISENTRESS RALTEGRAVIR Tablet, Chewable HUMAN PRESCRIPTION DRUG 12/21/2011 01/01/1900 Raltegravir Potassium NDA NDA203045 100 mg/1
IXEMPRA ixabepilone Kit HUMAN PRESCRIPTION DRUG 10/16/2007 01/01/1900 NDA NDA022065
IXEMPRA ixabepilone Kit HUMAN PRESCRIPTION DRUG 10/16/2007 01/01/1900 NDA NDA022065
JANUMET sitagliptin and metformin hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 02/02/2012 01/01/1900 Metformin Hydrochloride; Sitagliptin Phosphate NDA NDA202270 500; 50 mg/1; mg/1
JANUMET sitagliptin and metformin hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 02/02/2012 01/01/1900 Metformin Hydrochloride; Sitagliptin Phosphate NDA NDA202270 1000; 50 mg/1; mg/1
JANUMET sitagliptin and metformin hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 02/02/2012 01/01/1900 Metformin Hydrochloride; Sitagliptin Phosphate NDA NDA202270 1000; 100 mg/1; mg/1
JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/30/2007 01/01/1900 Metformin Hydrochloride; Sitagliptin Phosphate NDA NDA022044 500; 50 mg/1; mg/1
JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/30/2007 01/01/1900 Metformin Hydrochloride; Sitagliptin Phosphate NDA NDA022044 1000; 50 mg/1; mg/1
JANUVIA sitagliptin Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/16/2006 01/01/1900 Sitagliptin Phosphate NDA NDA021995 25 mg/1
JANUVIA sitagliptin Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/16/2006 01/01/1900 Sitagliptin Phosphate NDA NDA021995 50 mg/1
JANUVIA sitagliptin Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/16/2006 01/01/1900 Sitagliptin Phosphate NDA NDA021995 100 mg/1
Jevtana cabazitaxel Kit HUMAN PRESCRIPTION DRUG 06/17/2010 01/01/1900 NDA NDA201023
KENALOG-10 TRIAMCINOLONE ACETONIDE Injection, Suspension HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Triamcinolone Acetonide NDA NDA012041 10 mg/mL
KENALOG-40 TRIAMCINOLONE ACETONIDE Injection, Suspension HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Triamcinolone Acetonide NDA NDA014901 40 mg/mL
KEYTRUDA pembrolizumab Injection, Solution HUMAN PRESCRIPTION DRUG 01/15/2015 01/01/1900 Pembrolizumab BLA BLA125514 25 mg/mL
KEYTRUDA pembrolizumab Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 09/04/2014 01/01/1900 Pembrolizumab BLA BLA125514 50 mg/2mL
KIT FOR THE PREPARATION OF TC 99M PYROPHOSPHATE TechneScan PYP Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 03/20/2009 01/01/1900 Sodium Pyrophosphate; Stannous Chloride NDA NDA017538 11.9; 3.2 mg/10mL; mg/10mL
Kit for the Preparation of Technetium Tc 99m Sestamibi Tc 99m Sestamibi Injection HUMAN PRESCRIPTION DRUG 10/31/2011 01/01/1900 Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate ANDA ANDA078098 1 mg/10mL
Klonopin Clonazepam Tablet HUMAN PRESCRIPTION DRUG 06/02/1975 01/01/1900 Clonazepam NDA NDA017533 2 mg/1
Klonopin Clonazepam Tablet HUMAN PRESCRIPTION DRUG 06/02/1975 01/01/1900 Clonazepam NDA NDA017533 1 mg/1
Klonopin Clonazepam Tablet HUMAN PRESCRIPTION DRUG 06/02/1975 01/01/1900 Clonazepam NDA NDA017533 0.5 mg/1
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2000 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2013 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2000 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2013 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2000 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2013 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/07/2007 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2013 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 07/31/2009 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 06/26/2013 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 11/17/2005 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 11/17/2005 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 11/17/2005 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 07/04/2008 01/01/1900 BLA BLA103332
Kogenate FS Antihemophilic Factor (Recombinant) Kit PLASMA DERIVATIVE 07/31/2009 01/01/1900 BLA BLA103332
KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 11/05/2010 04/30/2017 Metformin Hydrochloride; Saxagliptin Hydrochloride NDA NDA200678 500; 5 mg/1; mg/1
KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 11/05/2010 05/31/2017 Metformin Hydrochloride; Saxagliptin Hydrochloride NDA NDA200678 1000; 2.5 mg/1; mg/1
KOMBIGLYZE SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 11/05/2010 03/31/2017 Metformin Hydrochloride; Saxagliptin Hydrochloride NDA NDA200678 1000; 5 mg/1; mg/1
Lasix furosemide Tablet HUMAN PRESCRIPTION DRUG 07/01/1966 01/01/1900 Furosemide NDA NDA016273 40 mg/1
Lasix furosemide Tablet HUMAN PRESCRIPTION DRUG 07/01/1966 01/01/1900 Furosemide NDA NDA016273 80 mg/1
Lasix furosemide Tablet HUMAN PRESCRIPTION DRUG 07/01/1966 01/01/1900 Furosemide NDA NDA016273 20 mg/1
LASTACAFT alcaftadine Solution/ Drops HUMAN PRESCRIPTION DRUG 11/01/2010 01/01/1900 Alcaftadine NDA NDA022134 2.5 mg/mL
LATISSE bimatoprost Solution/ Drops HUMAN PRESCRIPTION DRUG 01/26/2009 01/01/1900 Bimatoprost NDA NDA022369 0.3 mg/mL
Leukine SARGRAMOSTIM Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 05/01/1991 01/01/1900 Sargramostim BLA BLA103362 250 ug/mL
Leukine SARGRAMOSTIM Liquid HUMAN PRESCRIPTION DRUG 12/01/1996 01/01/1900 Sargramostim BLA BLA103362 500 ug/mL
Lincocin lincomycin hydrochloride Injection, Solution HUMAN PRESCRIPTION DRUG 12/29/1964 01/01/1900 Lincomycin Hydrochloride NDA NDA050317 300 mg/mL
Lithium Carbonate Lithium Carbonate Tablet, Extended Release HUMAN PRESCRIPTION DRUG 01/05/2004 01/01/1900 Lithium Carbonate ANDA ANDA076691 450 mg/1
Lithium Carbonate Lithium Carbonate Tablet, Extended Release HUMAN PRESCRIPTION DRUG 10/28/2004 01/01/1900 Lithium Carbonate ANDA ANDA076832 300 mg/1
Livalo pitavastatin calcium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 05/15/2010 01/01/1900 Pitavastatin Calcium NDA NDA022363 1 mg/1
Livalo pitavastatin calcium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 05/15/2010 01/01/1900 Pitavastatin Calcium NDA NDA022363 2 mg/1
Livalo pitavastatin calcium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 05/15/2010 01/01/1900 Pitavastatin Calcium NDA NDA022363 4 mg/1
Lomotil diphenoxylate hydrochloride and atropine sulfate Tablet HUMAN PRESCRIPTION DRUG 09/15/1960 01/01/1900 Atropine Sulfate; Diphenoxylate Hydrochloride NDA NDA012462 .025; 2.5 mg/1; mg/1
Lufyllin Dyphylline Tablet HUMAN PRESCRIPTION DRUG 08/31/1976 02/29/2016 Dyphylline ANDA ANDA084566 200 mg/1
LUMIGAN bimatoprost Solution/ Drops HUMAN PRESCRIPTION DRUG 09/10/2010 01/01/1900 Bimatoprost NDA NDA022184 0.1 mg/mL
LYSODREN MITOTANE Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Mitotane NDA NDA016885 500 mg/1
M-M-R II measles, mumps, and rubella virus vaccine live Injection, Powder, Lyophilized, For Suspension VACCINE 04/21/1971 01/01/1900 Measles Virus Strain Enders' Attenuated Edmonston Live Antigen; Mumps Virus Strain B Level BLA BLA101069 1000; 12500; 1000 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL
Marinol Dronabinol Capsule HUMAN PRESCRIPTION DRUG 07/13/2010 01/01/1900 Dronabinol NDA NDA018651 2.5 mg/1
Marinol Dronabinol Capsule HUMAN PRESCRIPTION DRUG 07/13/2010 01/01/1900 Dronabinol NDA NDA018651 5 mg/1
Marinol Dronabinol Capsule HUMAN PRESCRIPTION DRUG 07/13/2010 01/01/1900 Dronabinol NDA NDA018651 10 mg/1
MAXALT rizatriptan benzoate Tablet HUMAN PRESCRIPTION DRUG 06/29/1998 01/01/1900 Rizatriptan Benzoate NDA NDA020864 5 mg/1
MAXALT rizatriptan benzoate Tablet HUMAN PRESCRIPTION DRUG 06/29/1998 01/01/1900 Rizatriptan Benzoate NDA NDA020864 10 mg/1
MAXALT-MLT rizatriptan benzoate Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 06/29/1998 01/01/1900 Rizatriptan Benzoate NDA NDA020865 5 mg/1
MAXALT-MLT rizatriptan benzoate Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 06/29/1998 01/01/1900 Rizatriptan Benzoate NDA NDA020865 10 mg/1
MD-76R Diatrizoate meglumine and Diatrizoate sodium Solution HUMAN PRESCRIPTION DRUG 09/29/1989 01/01/1900 Diatrizoate Meglumine; Diatrizoate Sodium NDA NDA019292 660; 100 mg/mL; mg/mL
MD-GASTROVIEW diatrizoate meglumine and diatrizoate sodium Solution HUMAN PRESCRIPTION DRUG 08/31/2009 01/01/1900 Diatrizoate Meglumine; Diatrizoate Sodium ANDA ANDA087388 600; 100 mg/mL; mg/mL
Medrol methylprednisolone Tablet HUMAN PRESCRIPTION DRUG 09/20/2013 01/01/1900 Methylprednisolone NDA NDA011153 2 mg/1
Medrol methylprednisolone Tablet HUMAN PRESCRIPTION DRUG 10/24/1957 01/01/1900 Methylprednisolone NDA NDA011153 8 mg/1
Medrol methylprednisolone Tablet HUMAN PRESCRIPTION DRUG 10/24/1957 01/01/1900 Methylprednisolone NDA NDA011153 32 mg/1
Medrol methylprednisolone Tablet HUMAN PRESCRIPTION DRUG 10/24/1957 01/01/1900 Methylprednisolone NDA NDA011153 16 mg/1
Medrol methylprednisolone Tablet HUMAN PRESCRIPTION DRUG 10/24/1957 01/01/1900 Methylprednisolone NDA NDA011153 2 mg/1
Medrol methylprednisolone Tablet HUMAN PRESCRIPTION DRUG 10/24/1957 01/01/1900 Methylprednisolone NDA NDA011153 4 mg/1
Mefloquine Hydrochloride mefloquine hydrochloride Tablet HUMAN PRESCRIPTION DRUG 10/01/2004 01/01/1900 Mefloquine Hydrochloride ANDA ANDA076523 250 mg/1
MEGACE MEGESTROL ACETATE Suspension HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Megestrol Acetate NDA NDA020264 40 mg/mL
MEVACOR lovastatin Tablet HUMAN PRESCRIPTION DRUG 08/31/1987 01/01/1900 Lovastatin NDA NDA019643 20 mg/1
MEVACOR lovastatin Tablet HUMAN PRESCRIPTION DRUG 08/31/1987 01/01/1900 Lovastatin NDA NDA019643 40 mg/1
Mircera Methoxy polyethylene glycol-epoetin beta Injection, Solution HUMAN PRESCRIPTION DRUG 10/24/2014 01/01/1900 Methoxy Polyethylene Glycol-epoetin Beta BLA BLA125164 50 ug/.3mL
Mircera Methoxy polyethylene glycol-epoetin beta Injection, Solution HUMAN PRESCRIPTION DRUG 10/24/2014 01/01/1900 Methoxy Polyethylene Glycol-epoetin Beta BLA BLA125164 75 ug/.3mL
Mircera Methoxy polyethylene glycol-epoetin beta Injection, Solution HUMAN PRESCRIPTION DRUG 10/24/2014 01/01/1900 Methoxy Polyethylene Glycol-epoetin Beta BLA BLA125164 100 ug/.3mL
Mircera Methoxy polyethylene glycol-epoetin beta Injection, Solution HUMAN PRESCRIPTION DRUG 10/24/2014 01/01/1900 Methoxy Polyethylene Glycol-epoetin Beta BLA BLA125164 150 ug/.3mL
Mircera Methoxy polyethylene glycol-epoetin beta Injection, Solution HUMAN PRESCRIPTION DRUG 10/24/2014 01/01/1900 Methoxy Polyethylene Glycol-epoetin Beta BLA BLA125164 200 ug/.3mL
Mircera Methoxy polyethylene glycol-epoetin beta Injection, Solution HUMAN PRESCRIPTION DRUG 10/24/2014 01/01/1900 Methoxy Polyethylene Glycol-epoetin Beta BLA BLA125164 250 ug/.3mL
Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN Kit PLASMA DERIVATIVE 05/30/1990 01/01/1900 BLA BLA103953
Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN Kit PLASMA DERIVATIVE 05/30/1990 01/01/1900 BLA BLA103953
Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN Kit PLASMA DERIVATIVE 05/30/1990 01/01/1900 BLA BLA103953
Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN Kit PLASMA DERIVATIVE 03/04/2004 01/01/1900 BLA BLA103953
Mononine coagulation factor IX human Kit PLASMA DERIVATIVE 08/20/1992 01/01/1900 BLA BLA103957
Mononine coagulation factor IX human Kit PLASMA DERIVATIVE 08/20/1992 01/01/1900 BLA BLA103957
Mozobil PLERIXAFOR Solution HUMAN PRESCRIPTION DRUG 09/01/2013 01/01/1900 Plerixafor NDA NDA022311 24 mg/1.2mL
Multaq Dronedarone Tablet, Film Coated HUMAN PRESCRIPTION DRUG 07/01/2009 01/01/1900 Dronedarone NDA NDA022425 400 mg/1
MUSE Alprostadil Suppository HUMAN PRESCRIPTION DRUG 07/22/2011 01/01/1900 Alprostadil NDA NDA020700 125 ug/1
MUSE Alprostadil Suppository HUMAN PRESCRIPTION DRUG 07/22/2011 01/01/1900 Alprostadil NDA NDA020700 250 ug/1
MUSE Alprostadil Suppository HUMAN PRESCRIPTION DRUG 07/22/2011 01/01/1900 Alprostadil NDA NDA020700 500 ug/1
MUSE Alprostadil Suppository HUMAN PRESCRIPTION DRUG 07/22/2011 01/01/1900 Alprostadil NDA NDA020700 1000 ug/1
Mycobutin rifabutin Capsule HUMAN PRESCRIPTION DRUG 12/23/1992 01/01/1900 Rifabutin NDA NDA050689 150 mg/1
Naprosyn naproxen Suspension HUMAN PRESCRIPTION DRUG 03/23/1987 01/01/1900 Naproxen NDA NDA018965 125 mg/5mL
Naprosyn naproxen Tablet HUMAN PRESCRIPTION DRUG 03/11/1976 01/01/1900 Naproxen NDA NDA017581 250 mg/1
Naprosyn naproxen Tablet HUMAN PRESCRIPTION DRUG 03/11/1976 01/01/1900 Naproxen NDA NDA017581 375 mg/1
Naprosyn naproxen Tablet HUMAN PRESCRIPTION DRUG 03/11/1976 01/01/1900 Naproxen NDA NDA017581 500 mg/1
Natelle One doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 02/01/2015 01/01/1900 .alpha.-tocopherol; Ascorbic Acid; Calcium; Doconexent; Folic Acid; Icosapent; Iron; Pyrid UNAPPROVED DRUG OTHER 30; 30; 102; 250; 1; .625; 28; 25 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Navane Thiothixene Capsule HUMAN PRESCRIPTION DRUG 07/24/1967 01/01/1900 Thiothixene NDA NDA016584 1 mg/1
Navane Thiothixene Capsule HUMAN PRESCRIPTION DRUG 07/24/1967 01/01/1900 Thiothixene NDA NDA016584 2 mg/1
Navane Thiothixene Capsule HUMAN PRESCRIPTION DRUG 07/24/1967 01/01/1900 Thiothixene NDA NDA016584 5 mg/1
Navane Thiothixene Capsule HUMAN PRESCRIPTION DRUG 07/24/1967 01/01/1900 Thiothixene NDA NDA016584 10 mg/1
Navane Thiothixene Capsule HUMAN PRESCRIPTION DRUG 07/24/1967 01/01/1900 Thiothixene NDA NDA016584 20 mg/1
Nexplanon etonogestrel Implant HUMAN PRESCRIPTION DRUG 09/27/2013 01/01/1900 Etonogestrel NDA NDA021529 68 mg/1
Nexplanon etonogestrel Implant HUMAN PRESCRIPTION DRUG 07/17/2006 01/01/1900 Etonogestrel NDA NDA021529 68 mg/1
Nicotrol nicotine Inhalant HUMAN PRESCRIPTION DRUG 05/02/1997 01/01/1900 Nicotine NDA NDA020714 4 mg/1
Nicotrol nicotine Spray, Metered HUMAN PRESCRIPTION DRUG 05/22/1996 01/01/1900 Nicotine NDA NDA020385 10 mg/mL
Norpace disopyramide phosphate Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 07/20/1982 01/01/1900 Disopyramide Phosphate NDA NDA018655 100 mg/1
Norpace disopyramide phosphate Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 07/20/1982 01/01/1900 Disopyramide Phosphate NDA NDA018655 150 mg/1
Norpace disopyramide phosphate Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 09/01/1977 01/01/1900 Disopyramide Phosphate NDA NDA017447 100 mg/1
Norpace disopyramide phosphate Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 09/01/1977 01/01/1900 Disopyramide Phosphate NDA NDA017447 150 mg/1
NULOJIX BELATACEPT Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/15/2011 01/01/1900 Belatacept BLA BLA125288 250 mg/1
NuvaRing etonogestrel and ethinyl estradiol Insert, Extended Release HUMAN PRESCRIPTION DRUG 10/03/2001 01/01/1900 Ethinyl Estradiol; Etonogestrel NDA NDA021187 .015; .12 mg/d; mg/d
OCTREOSCAN Indium In -111 Pentetreotide Kit HUMAN PRESCRIPTION DRUG 05/01/2007 01/01/1900 NDA NDA020314
Oforta fludarabine phosphate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/31/2009 01/01/1900 Fludarabine Phosphate NDA NDA022273 10 mg/1
Ondansetron Hydrochloride Ondansetron Hydrochloride Solution HUMAN PRESCRIPTION DRUG 12/26/2006 01/01/1900 Ondansetron Hydrochloride ANDA ANDA076960 4 mg/5mL
ONGLYZA SAXAGLIPTIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 07/31/2009 04/30/2017 Saxagliptin Hydrochloride NDA NDA022350 2.5 mg/1
ONGLYZA SAXAGLIPTIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 07/31/2009 04/30/2017 Saxagliptin Hydrochloride NDA NDA022350 5 mg/1
OPDIVO nivolumab Injection HUMAN PRESCRIPTION DRUG 12/22/2014 01/01/1900 Nivolumab BLA BLA125554 10 mg/mL
OPDIVO nivolumab Injection HUMAN PRESCRIPTION DRUG 12/22/2014 01/01/1900 Nivolumab BLA BLA125554 10 mg/mL
OPTIMARK gadoversetamide Injection, Solution HUMAN PRESCRIPTION DRUG 01/22/2012 01/01/1900 Gadoversetamide NDA NDA020937 0.5 mmol/mL
OPTIMARK GADOVERSETAMIDE Injection, Solution HUMAN PRESCRIPTION DRUG 12/10/2010 01/01/1900 Gadoversetamide NDA NDA020975 0.5 mmol/mL
OPTIMARK gadoversetamide Injection, Solution HUMAN PRESCRIPTION DRUG 01/22/2012 01/01/1900 Gadoversetamide NDA NDA020976 0.5 mmol/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 10/17/2011 01/01/1900 Ioversol NDA NDA020923 678 mg/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 03/04/2012 01/01/1900 Ioversol NDA NDA019710 678 mg/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 03/04/2012 01/01/1900 Ioversol NDA NDA019710 509 mg/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 10/17/2011 01/01/1900 Ioversol NDA NDA020923 636 mg/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 03/04/2012 01/01/1900 Ioversol NDA NDA019710 636 mg/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 10/17/2011 01/01/1900 Ioversol NDA NDA020923 741 mg/mL
Optiray Ioversol Injection HUMAN PRESCRIPTION DRUG 03/04/2012 01/01/1900 Ioversol NDA NDA019710 741 mg/mL
Optivar Azelastine Hydrochloride Solution/ Drops HUMAN PRESCRIPTION DRUG 05/22/2000 01/01/1900 Azelastine Hydrochloride NDA NDA021127 0.5 mg/mL
Oral-B Cetylpyridinium Chloride Liquid HUMAN OTC DRUG 10/15/2005 01/01/1900 Cetylpyridinium Chloride OTC MONOGRAPH NOT FINAL part356 500 ug/mL
Oral-B Sodium Fluoride Liquid HUMAN OTC DRUG 10/15/2005 01/01/1900 Sodium Fluoride OTC MONOGRAPH NOT FINAL part355 500 ug/mL
Oral-B Fluorinse Mint Oral-B Fluorinse Mint Mouthwash HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 2 mg/mL
Oral-B Minute-Foam Banana Splitz Acidulated Phosphate Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 10 mg/g
Oral-B Minute-Foam Bubble Gum Acidulated Phosphate Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 10 mg/g
Oral-B Minute-Foam Grape Punch Acidulated Phosphate Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 10 mg/g
Oral-B Minute-Foam Mellow Mint Acidulated Phosphate Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 10 mg/g
Oral-B Minute-Foam Orang-A-Tangy Acidulated Phosphate Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Hydrofluoric Acid; Sodium Fluoride UNAPPROVED DRUG OTHER 2.3; 10 mg/g; mg/g
Oral-B Minute-Foam Strawberry Acidulated Phosphate Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 10 mg/g
Oral-B Neutra-Foam Mint Neutral Sodium Fluoride Aerosol HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 9 mg/g
Oral-B NeutraCare Mint Neutral Sodium Fluoride Gel HUMAN PRESCRIPTION DRUG 05/04/2000 01/01/1900 Sodium Fluoride UNAPPROVED DRUG OTHER 11 mg/g
ORENCIA abatacept Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 01/01/2009 01/01/1900 Abatacept BLA BLA125118 250 mg/15mL
ORENCIA abatacept Injection, Solution HUMAN PRESCRIPTION DRUG 07/29/2011 01/01/1900 Abatacept BLA BLA125118 125 mg/mL
Oxcarbazepine Oxcarbazepine Tablet HUMAN PRESCRIPTION DRUG 10/09/2007 01/01/1900 Oxcarbazepine ANDA ANDA077795 150 mg/1
Oxcarbazepine Oxcarbazepine Tablet HUMAN PRESCRIPTION DRUG 10/09/2007 01/01/1900 Oxcarbazepine ANDA ANDA077795 300 mg/1
Oxcarbazepine Oxcarbazepine Tablet HUMAN PRESCRIPTION DRUG 10/09/2007 01/01/1900 Oxcarbazepine ANDA ANDA077795 600 mg/1
OZURDEX dexamethasone Implant HUMAN PRESCRIPTION DRUG 09/01/2009 01/01/1900 Dexamethasone NDA NDA022315 0.7 mg/1
Pantoprazole Sodium pantoprazole sodium Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 01/31/2008 01/01/1900 Pantoprazole Sodium NDA NDA020987 20 mg/1
Pantoprazole Sodium pantoprazole sodium Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 01/31/2008 01/01/1900 Pantoprazole Sodium NDA NDA020987 40 mg/1
PedvaxHIB Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Injection, Suspension VACCINE 12/20/1989 01/01/1900 Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein BLA BLA103237 7.5 ug/.5mL
Pegasys peginterferon alfa-2a Injection, Solution HUMAN PRESCRIPTION DRUG 10/16/2002 01/01/1900 Peginterferon Alfa-2a BLA BLA103964 180 ug/mL
Pegasys peginterferon alfa-2a Kit HUMAN PRESCRIPTION DRUG 10/16/2002 07/31/2015 BLA BLA103964
Pegasys peginterferon alfa-2a Injection, Solution HUMAN PRESCRIPTION DRUG 03/29/2011 01/01/1900 Peginterferon Alfa-2a BLA BLA103964 180 ug/.5mL
Pegasys peginterferon alfa-2a Injection, Solution HUMAN PRESCRIPTION DRUG 11/01/2011 01/01/1900 Peginterferon Alfa-2a BLA BLA103964 135 ug/.5mL
Pegasys peginterferon alfa-2a Injection, Solution HUMAN PRESCRIPTION DRUG 11/01/2011 01/01/1900 Peginterferon Alfa-2a BLA BLA103964 180 ug/.5mL
Pfizerpen penicillin G potassium Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/2010 01/01/1900 Penicillin G Potassium ANDA ANDA060657 5000000 [iU]/1
Pfizerpen penicillin G potassium Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/2010 01/01/1900 Penicillin G Potassium ANDA ANDA060657 5000000 [iU]/1
Pfizerpen penicillin G potassium Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/2010 01/01/1900 Penicillin G Potassium ANDA ANDA060657 5000000 [iU]/1
Pfizerpen penicillin G potassium Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/2010 01/01/1900 Penicillin G Potassium ANDA ANDA060657 20000000 [iU]/1
Pfizerpen penicillin G potassium Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/2010 01/01/1900 Penicillin G Potassium ANDA ANDA060657 20000000 [iU]/1
Pfizerpen penicillin G potassium Powder, For Solution HUMAN PRESCRIPTION DRUG 06/01/2010 01/01/1900 Penicillin G Potassium ANDA ANDA060657 20000000 [iU]/1
Phisohex hexachlorophene Emulsion HUMAN PRESCRIPTION DRUG 06/11/1976 01/01/1900 Hexachlorophene NDA NDA006882 30 mg/mL
Phospholine Iodide echothiophate iodide Kit HUMAN PRESCRIPTION DRUG 12/04/1959 01/01/1900 NDA NDA011963
Pilocarpine Hydrochloride Pilocarpine Hydrochloride Tablet HUMAN PRESCRIPTION DRUG 12/22/2004 03/11/2016 Pilocarpine Hydrochloride ANDA ANDA076963 5 mg/1
Plaquenil Hydroxychloroquine Sulfate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/18/1955 01/01/1900 Hydroxychloroquine Sulfate NDA NDA009768 200 mg/1
PNEUMOVAX 23 pneumococcal vaccine polyvalent Injection, Solution VACCINE 07/07/1983 01/01/1900 Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Antigen; Streptococcus Pneumoniae BLA BLA101094 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL;
PNEUMOVAX 23 pneumococcal vaccine polyvalent Injection, Solution VACCINE 07/21/2014 01/01/1900 Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Antigen; Streptococcus Pneumoniae BLA BLA101094 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL;
PNEUMOVAX 23 pneumococcal vaccine polyvalent Injection, Solution VACCINE 07/07/1983 01/01/1900 Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Antigen; Streptococcus Pneumoniae BLA BLA101094 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL;
Polytrim polymyxin b sulfate and trimethoprim sulfate Solution/ Drops HUMAN PRESCRIPTION DRUG 01/23/1990 01/01/1900 Polymyxin B Sulfate; Trimethoprim Sulfate NDA NDA050567 100000; 1 [USP'U]/mL; mg/mL
PRAVACHOL PRAVASTATIN SODIUM Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Pravastatin Sodium NDA NDA019898 20 mg/1
PRAVACHOL PRAVASTATIN SODIUM Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Pravastatin Sodium NDA NDA019898 40 mg/1
PRAVACHOL PRAVASTATIN SODIUM Tablet HUMAN PRESCRIPTION DRUG 06/01/2009 01/01/1900 Pravastatin Sodium NDA NDA019898 80 mg/1
PRED-G gentamicin sulfate and prednisolone acetate Ointment HUMAN PRESCRIPTION DRUG 01/01/1990 01/01/1900 Gentamicin Sulfate; Prednisolone Acetate NDA NDA050612 3; 6 mg/g; mg/g
PRED-G gentamicin, prednisolone acetate Suspension/ Drops HUMAN PRESCRIPTION DRUG 02/19/1990 01/01/1900 Gentamicin; Prednisolone Acetate NDA NDA050586 3; 10 mg/mL; mg/mL
PredniSONE PredniSONE Tablet HUMAN PRESCRIPTION DRUG 02/13/2003 01/01/1900 Prednisone ANDA ANDA084122 10 mg/1
PredniSONE PredniSONE Tablet HUMAN PRESCRIPTION DRUG 02/13/2003 01/01/1900 Prednisone ANDA ANDA087342 20 mg/1
PredniSONE PredniSONE Tablet HUMAN PRESCRIPTION DRUG 03/14/2003 01/01/1900 Prednisone ANDA ANDA084283 50 mg/1
PreferaOB Cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niaci Tablet, Coated HUMAN PRESCRIPTION DRUG 04/28/2015 01/01/1900 .alpha.-tocopherol Succinate, D-; Biotin; Calcium Pantothenate; Cholecalciferol; Cupric Su UNAPPROVED DRUG OTHER 10; 30; 10; 400; .8; 12; 1; 6; 28; 17; 250; 50; 1.6; 65; 1.5; 4.5 [iU]/1; ug/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg
PreferaOB ONE ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine h Capsule, Liquid Filled HUMAN PRESCRIPTION DRUG 04/28/2015 01/01/1900 .alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Biotin; Calcium Pantothenate; Cholecalcife UNAPPROVED DRUG OTHER 10; 25; 30; 10; 400; 12; 1; 6; 22; 17; 175; 50; 200; 15 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1
PreferaOB plus DHA prenatal/postnatal multivitamin/multimineral Kit HUMAN PRESCRIPTION DRUG 02/01/2015 01/01/1900 UNAPPROVED DRUG OTHER
Pregnyl CHORIOGONADOTROPIN ALFA Kit HUMAN PRESCRIPTION DRUG 10/20/1976 01/01/1900 NDA NDA017692
Premarin estrogens, conjugated Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/2006 01/01/1900 Estrogens, Conjugated NDA NDA004782 0.3 mg/1
Premarin estrogens, conjugated Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/2006 01/01/1900 Estrogens, Conjugated NDA NDA004782 0.45 mg/1
Premarin estrogens, conjugated Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/2006 01/01/1900 Estrogens, Conjugated NDA NDA004782 0.625 mg/1
Premarin estrogens, conjugated Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/01/2006 01/01/1900 Estrogens, Conjugated NDA NDA004782 0.9 mg/1
Premarin estrogens, conjugated Tablet, Film Coated HUMAN PRESCRIPTION DRUG 09/01/2004 01/01/1900 Estrogens, Conjugated NDA NDA004782 1.25 mg/1
Premarin conjugated estrogens Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 12/01/1956 01/01/1900 Estrogens, Conjugated NDA NDA010402 25 mg/5mL
Premarin conjugated estrogens Cream HUMAN PRESCRIPTION DRUG 11/01/1978 01/01/1900 Estrogens, Conjugated NDA NDA020216 0.625 mg/g
Premphase conjugated estrogens and medroxyprogesterone acetate Kit HUMAN PRESCRIPTION DRUG 03/01/2012 01/01/1900 NDA NDA020527
Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 09/21/2009 01/01/1900 Estrogens, Conjugated; Medroxyprogesterone Acetate NDA NDA020527 .3; 1.5 mg/1; mg/1
Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 09/21/2009 01/01/1900 Estrogens, Conjugated; Medroxyprogesterone Acetate NDA NDA020527 .45; 1.5 mg/1; mg/1
Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 09/21/2009 01/01/1900 Estrogens, Conjugated; Medroxyprogesterone Acetate NDA NDA020527 .625; 2.5 mg/1; mg/1
Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 12/03/2012 01/01/1900 Estrogens, Conjugated; Medroxyprogesterone Acetate NDA NDA020527 .625; 5 mg/1; mg/1
Prepidil dinoprostone Gel HUMAN PRESCRIPTION DRUG 12/09/1992 01/01/1900 Dinoprostone NDA NDA019617 0.5 mg/3g
Prevnar Pneumococcal 7-valent Injection, Suspension VACCINE 03/01/2000 01/01/1900 Streptococcus Pneumoniae Type 14 Capsular Polysaccharide Diphtheria Crm197 Protein Conjuga BLA BLA103905 2; 2; 2; 2; 2; 4; 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
PREVNAR 13 pneumococcal 13-valent conjugate vaccine Injection, Suspension VACCINE 03/12/2010 01/01/1900 Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugat BLA BLA125324 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL;
Primaquine Phosphate Primaquine Phosphate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/15/2011 01/01/1900 Primaquine Phosphate NDA NDA008316 15 mg/1
PRIMAXIN imipenem and cilastatin sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 01/08/1987 01/01/1900 Cilastatin Sodium; Imipenem ANDA ANDA062756 250; 250 mg/100mL; mg/100mL
PRIMAXIN imipenem and cilastatin sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 01/08/1987 01/01/1900 Cilastatin Sodium; Imipenem ANDA ANDA062756 500; 500 mg/100mL; mg/100mL
PRIMAXIN imipenem and cilastatin sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/26/1985 01/01/1900 Cilastatin Sodium; Imipenem NDA NDA050587 250; 250 mg/100mL; mg/100mL
PRIMAXIN imipenem and cilastatin sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/26/1985 01/01/1900 Cilastatin Sodium; Imipenem NDA NDA050587 500; 500 mg/100mL; mg/100mL
PRINIVIL lisinopril Tablet HUMAN PRESCRIPTION DRUG 12/29/1987 01/01/1900 Lisinopril NDA NDA019558 5 mg/1
PRINIVIL lisinopril Tablet HUMAN PRESCRIPTION DRUG 12/29/1987 01/01/1900 Lisinopril NDA NDA019558 20 mg/1
PRINIVIL lisinopril Tablet HUMAN PRESCRIPTION DRUG 12/29/1987 01/01/1900 Lisinopril NDA NDA019558 10 mg/1
Pristiq desvenlafaxine succinate Tablet, Extended Release HUMAN PRESCRIPTION DRUG 04/01/2015 01/01/1900 Desvenlafaxine Succinate NDA NDA021992 25 mg/1
Pristiq desvenlafaxine succinate Tablet, Extended Release HUMAN PRESCRIPTION DRUG 05/01/2008 01/01/1900 Desvenlafaxine Succinate NDA NDA021992 50 mg/1
Pristiq desvenlafaxine succinate Tablet, Extended Release HUMAN PRESCRIPTION DRUG 05/01/2008 01/01/1900 Desvenlafaxine Succinate NDA NDA021992 100 mg/1
PROCTOFOAM pramoxine hydrochloride hydrocortisone acetate Aerosol, Foam HUMAN PRESCRIPTION DRUG 08/15/2014 01/01/1900 Hydrocortisone Acetate; Pramoxine Hydrochloride ANDA ANDA086457 100; 100 mg/10g; mg/10g
PROCTOFOAM pramoxine hydrochloride Aerosol, Foam HUMAN OTC DRUG 08/18/2014 01/01/1900 Pramoxine Hydrochloride OTC MONOGRAPH FINAL part346 150 mg/15g
PROMACTA eltrombopag olamine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 11/24/2008 01/01/1900 Eltrombopag Olamine NDA NDA022291 25 mg/1
PROMACTA eltrombopag olamine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 11/24/2008 01/01/1900 Eltrombopag Olamine NDA NDA022291 50 mg/1
PROMACTA eltrombopag olamine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/05/2009 01/01/1900 Eltrombopag Olamine NDA NDA022291 75 mg/1
PROMACTA eltrombopag olamine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 01/02/2012 01/01/1900 Eltrombopag Olamine NDA NDA022291 12.5 mg/1
PROMACTA eltrombopag olamine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/10/2014 01/01/1900 Eltrombopag Olamine NDA NDA022291 100 mg/1
Prometrium Progesterone Capsule HUMAN PRESCRIPTION DRUG 07/30/2010 01/01/1900 Progesterone NDA NDA019781 100 mg/1
Prometrium Progesterone Capsule HUMAN PRESCRIPTION DRUG 07/30/2010 01/01/1900 Progesterone NDA NDA019781 200 mg/1
PROPECIA finasteride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/19/1997 01/01/1900 Finasteride NDA NDA020788 1 mg/1
ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live Injection, Powder, Lyophilized, For Suspension VACCINE 09/06/2005 01/01/1900 Measles Virus Strain Enders' Attenuated Edmonston Live Antigen; Mumps Virus Strain B Level BLA BLA125108 1000; 20000; 1000; 9772 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL
PROSCAR FINASTERIDE Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/19/1992 01/01/1900 Finasteride NDA NDA020180 5 mg/1
PROSTIN alprostadil Injection, Solution HUMAN PRESCRIPTION DRUG 10/16/1981 01/01/1900 Alprostadil NDA NDA018484 500 ug/mL
Prostin dinoprostone Suppository HUMAN PRESCRIPTION DRUG 01/18/1978 01/01/1900 Dinoprostone NDA NDA017810 20 mg/1
Protonix PANTOPRAZOLE SODIUM Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 03/17/2014 01/01/1900 Pantoprazole Sodium NDA NDA020988 40 mg/10mL
Protonix PANTOPRAZOLE SODIUM Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 05/01/2013 01/01/1900 Pantoprazole Sodium NDA NDA020988 40 mg/10mL
Protonix PANTOPRAZOLE SODIUM Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 05/01/2000 01/01/1900 Pantoprazole Sodium NDA NDA020987 40 mg/1
Protonix PANTOPRAZOLE SODIUM Tablet, Delayed Release HUMAN PRESCRIPTION DRUG 05/01/2000 01/01/1900 Pantoprazole Sodium NDA NDA020987 20 mg/1
Protonix PANTOPRAZOLE SODIUM Granule, Delayed Release HUMAN PRESCRIPTION DRUG 02/29/2008 01/01/1900 Pantoprazole Sodium NDA NDA022020 40 mg/1
Protonix PANTOPRAZOLE SODIUM Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 05/01/2001 01/01/1900 Pantoprazole Sodium NDA NDA020988 40 mg/10mL
Protonix pantoprazole sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 05/01/2001 01/01/1900 Pantoprazole Sodium NDA NDA020988 40 mg/10mL
Provera medroxyprogesterone acetate Tablet HUMAN PRESCRIPTION DRUG 06/03/1959 01/01/1900 Medroxyprogesterone Acetate NDA NDA011839 10 mg/1
Provera medroxyprogesterone acetate Tablet HUMAN PRESCRIPTION DRUG 06/03/1959 01/01/1900 Medroxyprogesterone Acetate NDA NDA011839 2.5 mg/1
Provera medroxyprogesterone acetate Tablet HUMAN PRESCRIPTION DRUG 06/03/1959 01/01/1900 Medroxyprogesterone Acetate NDA NDA011839 5 mg/1
Prozac Fluoxetine hydrochloride Capsule, Delayed Release HUMAN PRESCRIPTION DRUG 03/16/2001 01/01/1900 Fluoxetine Hydrochloride NDA NDA021235 90 mg/1
Quinidine Gluconate Quinidine Gluconate Solution HUMAN PRESCRIPTION DRUG 03/01/1951 01/01/1900 Quinidine Gluconate NDA NDA007529 80 mg/mL
R-Gene Arginine Hydrochloride Injection, Solution HUMAN PRESCRIPTION DRUG 06/15/1976 01/01/1900 Arginine Hydrochloride NDA NDA016931 10 g/100mL
RAGWITEK Short Ragweed Pollen Allergen Extract Tablet STANDARDIZED ALLERGENIC 04/17/2014 01/01/1900 Ambrosia Artemisiifolia Pollen BLA BLA125478 12 [Amb'a'1'U]/1
Ramipril Ramipril Capsule HUMAN PRESCRIPTION DRUG 06/18/2008 01/01/1900 Ramipril ANDA ANDA077900 1.25 mg/1
Ramipril Ramipril Capsule HUMAN PRESCRIPTION DRUG 06/18/2008 01/01/1900 Ramipril ANDA ANDA077900 2.5 mg/1
Ramipril Ramipril Capsule HUMAN PRESCRIPTION DRUG 06/18/2008 01/01/1900 Ramipril ANDA ANDA077900 5 mg/1
Rapamune SIROLIMUS Solution HUMAN PRESCRIPTION DRUG 09/01/1999 01/01/1900 Sirolimus NDA NDA021083 1 mg/mL
Rapamune SIROLIMUS Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 03/01/2010 01/01/1900 Sirolimus NDA NDA021110 0.5 mg/1
Rapamune SIROLIMUS Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 07/01/2001 01/01/1900 Sirolimus NDA NDA021110 1 mg/1
Rapamune SIROLIMUS Tablet, Sugar Coated HUMAN PRESCRIPTION DRUG 07/01/2001 01/01/1900 Sirolimus NDA NDA021110 2 mg/1
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) Injection, Suspension VACCINE 07/23/1986 01/01/1900 Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen BLA BLA101066 5 ug/.5mL
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) Injection, Suspension VACCINE 07/23/1986 01/01/1900 Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen BLA BLA101066 40 ug/mL
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) Injection, Suspension VACCINE 07/23/1986 01/01/1900 Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen BLA BLA101066 10 ug/mL
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) Injection, Suspension VACCINE 07/23/1986 01/01/1900 Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen BLA BLA101066 5 ug/.5mL
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) Injection, Suspension VACCINE 07/23/1986 01/01/1900 Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen BLA BLA101066 10 ug/mL
REFRESH CELLUVISC carboxymethylcellulose sodium Gel HUMAN OTC DRUG 10/04/1989 01/01/1900 Carboxymethylcellulose Sodium OTC MONOGRAPH FINAL part349 10 mg/mL
REFRESH Classic Polyvinyl Alcohol, Povidone Solution/ Drops HUMAN OTC DRUG 09/12/1985 01/01/1900 Polyvinyl Alcohol; Povidone OTC MONOGRAPH FINAL part349 14; 6 mg/mL; mg/mL
REFRESH LACRI-LUBE mineral oil, petrolatum Ointment HUMAN OTC DRUG 12/15/1977 01/01/1900 Mineral Oil; Petrolatum OTC MONOGRAPH FINAL part349 425; 568 mg/g; mg/g
REFRESH LIQUIGEL Carboxymethylcellulose sodium Gel HUMAN OTC DRUG 10/04/2001 01/01/1900 Carboxymethylcellulose Sodium OTC MONOGRAPH FINAL part349 10 mg/mL
REFRESH OPTIVE carboxymethylcellulose sodium and glycerin Solution/ Drops HUMAN OTC DRUG 09/06/2006 01/01/1900 Carboxymethylcellulose Sodium; Glycerin OTC MONOGRAPH FINAL part349 5; 9 mg/mL; mg/mL
Refresh Optive Carboxymethylcellulose Sodium, Glycerin Solution/ Drops HUMAN OTC DRUG 08/22/2008 01/01/1900 Carboxymethylcellulose Sodium; Glycerin OTC MONOGRAPH FINAL part349 5; 9 mg/mL; mg/mL
REFRESH OPTIVE Advanced carboxymethylcellulose sodium, glycerin, and polysorbate 80 Solution/ Drops HUMAN OTC DRUG 11/30/2011 01/01/1900 Carboxymethylcellulose Sodium; Glycerin; Polysorbate 80 OTC MONOGRAPH FINAL part349 5; 10; 5 mg/mL; mg/mL; mg/mL
REFRESH OPTIVE Advanced carboxymethylcellulose sodium, glycerin, polysorbate 80 Solution/ Drops HUMAN OTC DRUG 01/15/2013 01/01/1900 Carboxymethylcellulose Sodium; Glycerin; Polysorbate 80 OTC MONOGRAPH FINAL part349 5; 10; 5 mg/mL; mg/mL; mg/mL
REFRESH P.M. mineral oil, petrolatum Ointment HUMAN OTC DRUG 04/23/1990 01/01/1900 Mineral Oil; Petrolatum OTC MONOGRAPH FINAL part349 425; 573 mg/g; mg/g
REFRESH PLUS carboxymethylcellulose sodium Solution/ Drops HUMAN OTC DRUG 10/09/1996 01/01/1900 Carboxymethylcellulose Sodium OTC MONOGRAPH FINAL part349 5 mg/mL
REFRESH TEARS carboxymethylcellulose sodium Solution/ Drops HUMAN OTC DRUG 05/16/1997 01/01/1900 Carboxymethylcellulose Sodium OTC MONOGRAPH FINAL part349 5 mg/mL
Relpax eletriptan hydrobromide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/26/2002 01/01/1900 Eletriptan Hydrobromide NDA NDA021016 20 mg/1
Relpax eletriptan hydrobromide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/26/2002 01/01/1900 Eletriptan Hydrobromide NDA NDA021016 40 mg/1
REMERON MIRTAZAPINE Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/11/1997 01/01/1900 Mirtazapine NDA NDA020415 45 mg/1
REMERON MIRTAZAPINE Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/14/1996 01/01/1900 Mirtazapine NDA NDA020415 30 mg/1
REMERON MIRTAZAPINE Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/14/1996 01/01/1900 Mirtazapine NDA NDA020415 15 mg/1
REMERONSOLTAB MIRTAZAPINE Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 01/12/2001 01/01/1900 Mirtazapine NDA NDA021208 15 mg/1
REMERONSOLTAB MIRTAZAPINE Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 01/12/2001 01/01/1900 Mirtazapine NDA NDA021208 30 mg/1
REMERONSOLTAB MIRTAZAPINE Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 01/12/2001 01/01/1900 Mirtazapine NDA NDA021208 45 mg/1
REOPRO abciximab Injection, Solution HUMAN PRESCRIPTION DRUG 12/16/1993 01/01/1900 Abciximab BLA BLA103575 2 mg/mL
REQUIP ropinirole hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 11/20/2008 01/01/1900 Ropinirole Hydrochloride NDA NDA022008 12 mg/1
REQUIP ropinirole hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 08/03/2009 01/01/1900 Ropinirole Hydrochloride NDA NDA022008 6 mg/1
REQUIP ropinirole hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 06/30/2008 01/01/1900 Ropinirole Hydrochloride NDA NDA022008 2 mg/1
REQUIP ropinirole hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 06/30/2008 01/01/1900 Ropinirole Hydrochloride NDA NDA022008 4 mg/1
REQUIP ropinirole hydrochloride Tablet, Film Coated, Extended Release HUMAN PRESCRIPTION DRUG 06/30/2008 01/01/1900 Ropinirole Hydrochloride NDA NDA022008 8 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/10/1997 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 0.25 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/10/1997 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 0.5 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/01/1997 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 1 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/03/1997 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 2 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 10/10/1997 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 5 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 06/19/2001 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 3 mg/1
REQUIP ropinirole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 09/21/1999 01/01/1900 Ropinirole Hydrochloride NDA NDA020658 4 mg/1
RESTASIS cyclosporine Emulsion HUMAN PRESCRIPTION DRUG 04/01/2003 01/01/1900 Cyclosporine NDA NDA050790 0.5 mg/mL
REYATAZ ATAZANAVIR Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/2003 01/01/1900 Atazanavir Sulfate NDA NDA021567 300 mg/1
REYATAZ ATAZANAVIR Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/2003 07/31/2015 Atazanavir Sulfate NDA NDA021567 100 mg/1
REYATAZ ATAZANAVIR Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/2003 01/01/1900 Atazanavir Sulfate NDA NDA021567 150 mg/1
REYATAZ ATAZANAVIR Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/2003 01/01/1900 Atazanavir Sulfate NDA NDA021567 200 mg/1
REYATAZ ATAZANAVIR Powder HUMAN PRESCRIPTION DRUG 12/19/2014 01/01/1900 Atazanavir Sulfate NDA NDA206352 50 mg/1
Risperidone Risperidone Solution HUMAN PRESCRIPTION DRUG 07/29/2009 01/01/1900 Risperidone ANDA ANDA076904 1 mg/mL
ROBITUSSIN LINGERING COLD LONG-ACTING COUGH dextromethorphan HBr Liquid HUMAN OTC DRUG 06/15/2011 01/01/1900 Dextromethorphan Hydrobromide OTC MONOGRAPH FINAL part341 15 mg/5mL
ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS dextromethorphan hbr Capsule, Liquid Filled HUMAN OTC DRUG 06/06/2011 01/01/1900 Dextromethorphan Hydrobromide OTC MONOGRAPH FINAL part341 15 mg/1
Robitussin Maximum Strength Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin Capsule, Liquid Filled HUMAN OTC DRUG 05/23/2013 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin OTC MONOGRAPH FINAL part341 10; 200 mg/1; mg/1
Robitussin Maximum Strength Nighttime Cough DM DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE Liquid HUMAN OTC DRUG 03/01/2013 01/01/1900 Dextromethorphan Hydrobromide; Doxylamine Succinate OTC MONOGRAPH FINAL part341 30; 12.5 mg/10mL; mg/10mL
Robitussin Medi-Soothers Cough DM dextromethorphan hydrobromide and menthol Lozenge HUMAN OTC DRUG 09/01/2014 01/01/1900 Dextromethorphan Hydrobromide; Menthol, Unspecified Form OTC MONOGRAPH FINAL part341 5; 5 mg/1; mg/1
Robitussin Mucus Plus Chest Congestion Guaifenesin Liquid HUMAN OTC DRUG 07/18/2012 01/01/1900 Guaifenesin OTC MONOGRAPH FINAL part341 200 mg/10mL
ROBITUSSIN NIGHT TIME COUGH AND COLD diphenhydramine HCl, phenylephrine HCl Liquid HUMAN OTC DRUG 02/09/2006 01/01/1900 Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 6.25; 2.5 mg/5mL; mg/5mL
Robitussin Peak Cold Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin Liquid HUMAN OTC DRUG 06/15/2011 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin OTC MONOGRAPH FINAL part341 10; 100 mg/5mL; mg/5mL
ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE Capsule, Liquid Filled HUMAN OTC DRUG 04/15/2012 01/01/1900 Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 10; 5 mg/1; mg/1; mg/1
ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM dextromethorphan HBr, guaifenesin Liquid HUMAN OTC DRUG 06/15/2011 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin OTC MONOGRAPH FINAL part341 10; 200 mg/5mL; mg/5mL
ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD dextromethorphan HBr, guaifenesin, phenylephrine HCl Liquid HUMAN OTC DRUG 06/15/2011 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Robitussin Peak Cold Multi-Symptom Cold dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride Liquid HUMAN OTC DRUG 06/12/2011 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 10; 100; 5 mg/5mL; mg/5mL; mg/5mL
ROBITUSSIN PEAK COLD NASAL RELIEF acetaminophen, phenylephrine HCl Tablet HUMAN OTC DRUG 06/06/2011 01/01/1900 Acetaminophen; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 5 mg/1; mg/1
ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE Capsule, Liquid Filled HUMAN OTC DRUG 04/15/2012 01/01/1900 Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate OTC MONOGRAPH FINAL part341 325; 15; 6.25 mg/1; mg/1; mg/1
ROBITUSSIN PEAK COLD NIGHTTIME MULTI-SYMPTOM COLD acetaminophen, diphenhydramine HCl, phenylephrine HCl Liquid HUMAN OTC DRUG 06/15/2011 01/01/1900 Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 160; 6.25; 2.5 mg/5mL; mg/5mL; mg/5mL
ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF acetaminophen, chlorpheniramine maleate, phenylephrine HCl Tablet HUMAN OTC DRUG 06/06/2011 01/01/1900 Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 2; 5 mg/1; mg/1; mg/1
Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin Liquid HUMAN OTC DRUG 06/15/2011 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin OTC MONOGRAPH FINAL part341 10; 100 mg/5mL; mg/5mL
Robitussin Severe Multi-Symptom Cough Cold Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride Liquid HUMAN OTC DRUG 05/01/2015 01/01/1900 Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
ROBITUSSIN TO GO COUGH AND CHEST CONGESTION DM dextromethorphan HBr, guaifenesin Liquid HUMAN OTC DRUG 07/31/2007 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin OTC MONOGRAPH FINAL part341 2; 20 mg/mL; mg/mL
ROBITUSSIN TO GO COUGH AND COLD CF dextromethorphan HBr, guaifenesin, phenylephrine HCl Solution HUMAN OTC DRUG 01/07/2008 01/01/1900 Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 20; 200; 10 mg/10mL; mg/10mL; mg/10mL
Rocephin ceftriaxone sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 08/13/1993 01/01/1900 Ceftriaxone Sodium ANDA ANDA063239 500 mg/1
Rocephin ceftriaxone sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 08/13/1993 01/01/1900 Ceftriaxone Sodium ANDA ANDA063239 1 g/1
RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent Solution VACCINE 02/03/2006 01/01/1900 Human Rotavirus A Type G1p7(5) Strain Wi79 Live Antigen; Human Rotavirus A Type G2p7(5) St BLA BLA125122 2200000; 2800000; 2200000; 2000000; 2300000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL
SANCTURA trospium chloride Tablet HUMAN PRESCRIPTION DRUG 12/01/2007 09/19/2015 Trospium Chloride NDA NDA021595 20 mg/1
SAPHRIS Asenapine Maleate Tablet HUMAN PRESCRIPTION DRUG 08/13/2009 01/01/1900 Asenapine Maleate NDA NDA022117 5 mg/1
SAPHRIS Asenapine Maleate Tablet HUMAN PRESCRIPTION DRUG 08/13/2009 01/01/1900 Asenapine Maleate NDA NDA022117 10 mg/1
SAPHRIS Asenapine Maleate Tablet HUMAN PRESCRIPTION DRUG 06/21/2010 01/01/1900 Asenapine Maleate NDA NDA022117 5 mg/1
SAPHRIS Asenapine Maleate Tablet HUMAN PRESCRIPTION DRUG 06/21/2010 01/01/1900 Asenapine Maleate NDA NDA022117 10 mg/1
SINEMET carbidopa and levodopa Tablet HUMAN PRESCRIPTION DRUG 05/02/1975 01/01/1900 Carbidopa; Levodopa NDA NDA017555 10; 100 mg/1; mg/1
SINEMET carbidopa and levodopa Tablet HUMAN PRESCRIPTION DRUG 05/02/1975 01/01/1900 Carbidopa; Levodopa NDA NDA017555 25; 100 mg/1; mg/1
SINEMET carbidopa and levodopa Tablet HUMAN PRESCRIPTION DRUG 05/02/1975 01/01/1900 Carbidopa; Levodopa NDA NDA017555 25; 250 mg/1; mg/1
SINEMET carbidopa and levodopa Tablet, Extended Release HUMAN PRESCRIPTION DRUG 05/30/1991 01/01/1900 Carbidopa; Levodopa NDA NDA019856 25; 100 mg/1; mg/1
SINEMET carbidopa and levodopa Tablet, Extended Release HUMAN PRESCRIPTION DRUG 05/30/1991 01/01/1900 Carbidopa; Levodopa NDA NDA019856 50; 200 mg/1; mg/1
SINGULAIR montelukast sodium Tablet, Film Coated HUMAN PRESCRIPTION DRUG 02/20/1998 01/01/1900 Montelukast Sodium NDA NDA020829 10 mg/1
SINGULAIR montelukast sodium Tablet, Chewable HUMAN PRESCRIPTION DRUG 02/20/1998 01/01/1900 Montelukast Sodium NDA NDA020830 5 mg/1
SINGULAIR montelukast sodium Granule HUMAN PRESCRIPTION DRUG 07/26/2002 01/01/1900 Montelukast Sodium NDA NDA021409 4 mg/1
SINGULAIR montelukast sodium Tablet, Chewable HUMAN PRESCRIPTION DRUG 02/20/1998 01/01/1900 Montelukast Sodium NDA NDA020830 4 mg/1
SKIN MEDICA Purifying Foaming Wash salicylic acid Liquid HUMAN OTC DRUG 01/01/2013 01/01/1900 Salicylic Acid OTC MONOGRAPH FINAL part333D 20 mg/mL
SkinMedica Acne Treatment benzoyl peroxide Lotion HUMAN OTC DRUG 01/01/2013 01/01/1900 Benzoyl Peroxide OTC MONOGRAPH NOT FINAL part333D 25 mg/g
SkinMedica Daily Physical Defense SPF 30 Sunscreen Titanium Dioxide, zinc oxide Cream HUMAN OTC DRUG 01/01/2013 01/01/1900 Titanium Dioxide; Zinc Oxide OTC MONOGRAPH NOT FINAL part352 73; 34 mg/g; mg/g
SkinMedica Environmental Defense Sunscreen SPF 50 Octinoxate, Octisalate, Octocrylene, Oxybenzone, Zinc Oxide Cream HUMAN OTC DRUG 01/01/2013 01/01/1900 Octinoxate; Octisalate; Octocrylene; Oxybenzone; Zinc Oxide OTC MONOGRAPH NOT FINAL part352 75; 50; 20; 60; 33 mg/g; mg/g; mg/g; mg/g; mg/g
SkinMedica Purifying Toner Salicylic Acid Liquid HUMAN OTC DRUG 01/01/2013 10/31/2015 Salicylic Acid OTC MONOGRAPH FINAL part333D 20 mg/mL
SkinMedica TNS Ultimate Daily Moisturizer Sunscreen SPF 20 octinoxate, zinc oxide Cream HUMAN OTC DRUG 01/01/2013 01/01/1900 Octinoxate; Zinc Oxide OTC MONOGRAPH NOT FINAL part352 75; 53 mg/g; mg/g
SODIUM CHLORIDE sodium chloride Injection HUMAN PRESCRIPTION DRUG 09/01/2012 01/01/1900 Sodium Chloride NDA NDA021569 0.9 mg/mL
SODIUM IODIDE I 123 sodium iodide i 123 Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 04/11/2007 01/01/1900 Sodium Iodide I-123 ANDA ANDA071909 100 uCi/1
SODIUM IODIDE I 123 sodium iodide i 123 Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 04/11/2007 01/01/1900 Sodium Iodide I-123 ANDA ANDA071910 200 uCi/1
SODIUM IODIDE I 131 sodium iodide i 131 Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 01/25/2012 01/01/1900 Sodium Iodide I-131 NDA NDA016517 1 mCi/mL
Sodium Iodide I-131 sodium iodide, i-131 Solution HUMAN PRESCRIPTION DRUG 08/22/2011 01/01/1900 Sodium Iodide I-131 NDA NDA016515 5 mCi/mL
Sodium Iodide I-131 sodium iodide, i-131 Solution HUMAN PRESCRIPTION DRUG 08/22/2011 01/01/1900 Sodium Iodide I-131 NDA NDA016515 25 mCi/mL
Solu-Cortef hydrocortisone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/27/1955 01/01/1900 Hydrocortisone Sodium Succinate NDA NDA009866 1000 mg/8mL
Solu-Cortef hydrocortisone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/27/1955 01/01/1900 Hydrocortisone Sodium Succinate NDA NDA009866 100 mg/2mL
Solu-Cortef hydrocortisone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/27/1955 01/01/1900 Hydrocortisone Sodium Succinate NDA NDA009866 250 mg/2mL
Solu-Cortef hydrocortisone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/27/1955 01/01/1900 Hydrocortisone Sodium Succinate NDA NDA009866 500 mg/4mL
Solu-Cortef hydrocortisone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/27/1955 01/01/1900 Hydrocortisone Sodium Succinate NDA NDA009866 100 mg/2mL
Solu-Medrol methylprednisolone sodium succinate Kit HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 NDA NDA011856
SOLU-MEDROL methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 1 g/mL
SOLU-MEDROL methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 500 mg/mL
SOLU-MEDROL methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 1 g/mL
SOLU-MEDROL methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 500 mg/mL
Solu-Medrol methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 125 mg/mL
SOLU-MEDROL methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 125 mg/mL
Solu-Medrol methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 40 mg/mL
SOLU-MEDROL methylprednisolone sodium succinate Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/02/1959 01/01/1900 Methylprednisolone Sodium Succinate NDA NDA011856 40 mg/mL
Soma Carisoprodol Tablet HUMAN PRESCRIPTION DRUG 07/01/1959 01/01/1900 Carisoprodol NDA NDA011792 350 mg/1
Soma Carisoprodol Tablet HUMAN PRESCRIPTION DRUG 09/01/2007 01/01/1900 Carisoprodol NDA NDA011792 250 mg/1
SOMAVERT pegvisomant Kit HUMAN PRESCRIPTION DRUG 05/25/2003 01/01/1900 NDA NDA021106
SOMAVERT pegvisomant Kit HUMAN PRESCRIPTION DRUG 05/25/2003 01/01/1900 NDA NDA021106
SOMAVERT pegvisomant Kit HUMAN PRESCRIPTION DRUG 05/25/2003 01/01/1900 NDA NDA021106
SOMAVERT pegvisomant Kit HUMAN PRESCRIPTION DRUG 07/31/2014 01/01/1900 NDA NDA021106
SOMAVERT pegvisomant Kit HUMAN PRESCRIPTION DRUG 07/31/2014 01/01/1900 NDA NDA021106
SPRYCEL dasatinib Tablet HUMAN PRESCRIPTION DRUG 05/30/2008 01/01/1900 Dasatinib NDA NDA021986 100 mg/1
SPRYCEL dasatinib Tablet HUMAN PRESCRIPTION DRUG 10/28/2010 01/01/1900 Dasatinib NDA NDA021986 80 mg/1
SPRYCEL dasatinib Tablet HUMAN PRESCRIPTION DRUG 10/28/2010 01/01/1900 Dasatinib NDA NDA021986 140 mg/1
SPRYCEL dasatinib Tablet HUMAN PRESCRIPTION DRUG 06/27/2006 01/01/1900 Dasatinib NDA NDA021986 70 mg/1
SPRYCEL dasatinib Tablet HUMAN PRESCRIPTION DRUG 06/27/2006 01/01/1900 Dasatinib NDA NDA021986 20 mg/1
SPRYCEL dasatinib Tablet HUMAN PRESCRIPTION DRUG 06/27/2006 01/01/1900 Dasatinib NDA NDA021986 50 mg/1
STERILE DILUENT Sterile Water Injection VACCINE 05/25/2006 01/01/1900 BLA BLA125123
Stimate desmopressin acetate Spray, Metered HUMAN PRESCRIPTION DRUG 09/16/2011 01/01/1900 Desmopressin Acetate NDA NDA020355 1.5 mg/mL
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 03/01/2006 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 80 mg/1
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 03/01/2006 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 100 mg/1
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/10/2003 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 18 mg/1
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/10/2003 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 60 mg/1
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/10/2003 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 10 mg/1
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/10/2003 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 25 mg/1
Strattera Atomoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/10/2003 01/01/1900 Atomoxetine Hydrochloride NDA NDA021411 40 mg/1
Strattera Atomoxetine hydrochloride Kit HUMAN PRESCRIPTION DRUG 08/31/2014 01/01/1900 NDA NDA021411
Strattera Atomoxetine hydrochloride Kit HUMAN PRESCRIPTION DRUG 08/31/2014 01/01/1900 NDA NDA021411
Strattera Atomoxetine hydrochloride Kit HUMAN PRESCRIPTION DRUG 08/31/2014 01/01/1900 NDA NDA021411
STROMECTOL ivermectin Tablet HUMAN PRESCRIPTION DRUG 11/22/1996 01/01/1900 Ivermectin NDA NDA050742 3 mg/1
Symbyax Olanzapine and Fluoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 04/09/2007 01/01/1900 Fluoxetine Hydrochloride; Olanzapine NDA NDA021520 25; 3 mg/1; mg/1
Symbyax Olanzapine and Fluoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/19/2004 01/01/1900 Fluoxetine Hydrochloride; Olanzapine NDA NDA021520 25; 6 mg/1; mg/1
Symbyax Olanzapine and Fluoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/19/2004 01/01/1900 Fluoxetine Hydrochloride; Olanzapine NDA NDA021520 25; 12 mg/1; mg/1
Symbyax Olanzapine and Fluoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/19/2004 01/01/1900 Fluoxetine Hydrochloride; Olanzapine NDA NDA021520 50; 6 mg/1; mg/1
Symbyax Olanzapine and Fluoxetine hydrochloride Capsule HUMAN PRESCRIPTION DRUG 01/19/2004 01/01/1900 Fluoxetine Hydrochloride; Olanzapine NDA NDA021520 50; 12 mg/1; mg/1
Synarel nafarelin acetate Spray, Metered HUMAN PRESCRIPTION DRUG 02/13/1990 01/01/1900 Nafarelin Acetate NDA NDA019886 2 mg/mL
Tamiflu oseltamivir phosphate Capsule HUMAN PRESCRIPTION DRUG 10/27/1999 01/01/1900 Oseltamivir Phosphate NDA NDA021087 75 mg/1
Tamiflu oseltamivir phosphate Capsule HUMAN PRESCRIPTION DRUG 10/27/1999 01/01/1900 Oseltamivir Phosphate NDA NDA021087 45 mg/1
Tamiflu oseltamivir phosphate Capsule HUMAN PRESCRIPTION DRUG 10/27/1999 01/01/1900 Oseltamivir Phosphate NDA NDA021087 30 mg/1
Tamiflu Oseltamivir Phosphate Powder, For Suspension HUMAN PRESCRIPTION DRUG 08/01/2013 01/01/1900 Oseltamivir Phosphate NDA NDA021246 6 mg/mL
TAZORAC tazarotene Gel HUMAN PRESCRIPTION DRUG 08/01/1997 01/01/1900 Tazarotene NDA NDA020600 1 mg/g
TAZORAC tazarotene Gel HUMAN PRESCRIPTION DRUG 08/01/1997 01/01/1900 Tazarotene NDA NDA020600 0.5 mg/g
TAZORAC tazarotene Cream HUMAN PRESCRIPTION DRUG 11/15/2000 01/01/1900 Tazarotene NDA NDA021184 0.5 mg/g
TAZORAC tazarotene Cream HUMAN PRESCRIPTION DRUG 11/13/2000 01/01/1900 Tazarotene NDA NDA021184 1 mg/g
TechneScan HDP Technetium Tc 99m Oxidronate Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 02/27/2007 01/01/1900 Oxidronate Disodium NDA NDA018321 3.15 mg/1
TechneScan MAG3 Mertiatide Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/15/1990 01/01/1900 Betiatide NDA NDA019882 1 mg/1
THALLOUS CHLORIDE Tl 201 thallous chloride, Tl 201 Injection, Solution HUMAN PRESCRIPTION DRUG 02/29/2012 01/01/1900 Thallous Chloride Tl-201 NDA NDA018150 1 mCi/mL
Theraflu Acetaminophen, Diphenhydramine HCl, Phenylepherine HCl Syrup HUMAN OTC DRUG 05/04/2007 01/01/1900 Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL
Theraflu Acetaminophen, Dextromethorphan HBr, Phenylepherine HCl Syrup HUMAN OTC DRUG 05/04/2007 01/01/1900 Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
Theraflu Acetaminophen, Guaifenesin Powder, For Solution HUMAN OTC DRUG 06/23/2006 01/01/1900 Acetaminophen; Guaifenesin OTC MONOGRAPH FINAL part341 1000; 400 mg/1; mg/1
Theraflu ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE Powder, For Solution HUMAN OTC DRUG 09/24/2012 01/01/1900 Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 650; 25; 10 mg/1; mg/1; mg/1
Theraflu ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE Powder, For Solution HUMAN OTC DRUG 09/24/2012 01/01/1900 Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 650; 20; 10 mg/1; mg/1; mg/1
Theraflu Acetaminophen, Diphenhydramine HCl, Phenylepherine HCl Syrup HUMAN OTC DRUG 07/03/2007 01/01/1900 Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL
Theraflu Acetaminophen, Guaifenesin and Phenylephrine HCl Syrup HUMAN OTC DRUG 08/06/2005 01/01/1900 Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride OTC MONOGRAPH FINAL part341 325; 200; 5 mg/15mL; mg/15mL; mg/15mL
TICE BCG BACILLUS CALMETTE-GUERIN Powder, For Suspension HUMAN PRESCRIPTION DRUG 08/24/1990 01/01/1900 Bacillus Calmette-guerin Substrain Tice Live Antigen BLA BLA102821 50 mg/50mL
TIMENTIN ticarcillin disodium and clavulanate potassium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 10/22/1990 07/31/2015 Clavulanate Potassium; Ticarcillin Disodium NDA NDA050590 1; 30 mg/mL; mg/mL
TIMENTIN ticarcillin disodium and clavulanate potassium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 10/22/1990 07/31/2015 Clavulanate Potassium; Ticarcillin Disodium NDA NDA050590 1; 30 mg/mL; mg/mL
Torisel temsirolimus Kit HUMAN PRESCRIPTION DRUG 07/01/2007 01/01/1900 NDA NDA022088
TORSEMIDE TORSEMIDE Tablet HUMAN PRESCRIPTION DRUG 03/03/2005 01/01/1900 Torsemide ANDA ANDA076943 20 mg/1
TOUJEO insulin glargine Injection, Solution HUMAN PRESCRIPTION DRUG 02/25/2015 01/01/1900 Insulin Glargine NDA NDA206538 300 U/mL
Trecator ethionamide Tablet, Film Coated HUMAN PRESCRIPTION DRUG 11/08/2004 01/01/1900 Ethionamide NDA NDA013026 250 mg/1
Trulicity Dulaglutide Injection, Solution HUMAN PRESCRIPTION DRUG 11/07/2014 01/01/1900 Dulaglutide BLA BLA125469 0.75 mg/.5mL
Trulicity Dulaglutide Injection, Solution HUMAN PRESCRIPTION DRUG 11/07/2014 01/01/1900 Dulaglutide BLA BLA125469 1.5 mg/.5mL
Trumenba meningococcal group B vaccine Injection, Suspension VACCINE 11/05/2014 01/01/1900 Neisseria Meningitidis Serogroup B Recombinant Lp2086 A05 Protein Variant Antigen; Neisser BLA BLA125549 60; 60 ug/.5mL; ug/.5mL
TRUSOPT dorzolamide hydrochloride Solution HUMAN PRESCRIPTION DRUG 12/09/1994 01/01/1900 Dorzolamide Hydrochloride NDA NDA020408 20 mg/mL
Tygacil TIGECYCLINE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 06/01/2005 01/01/1900 Tigecycline NDA NDA021821 50 mg/5mL
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/16/1996 01/01/1900 Molybdenum Mo-99 NDA NDA017243 1 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/16/1996 01/01/1900 Molybdenum Mo-99 NDA NDA017243 1.5 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/16/1996 01/01/1900 Molybdenum Mo-99 NDA NDA017243 2 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/16/1996 01/01/1900 Molybdenum Mo-99 NDA NDA017243 2.5 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/16/1996 01/01/1900 Molybdenum Mo-99 NDA NDA017243 3 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 3.5 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 5 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 6 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 7.5 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 11 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 14 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 16 Ci/1
Ultra-TechneKow Technetium Tc-99m Generator Injection, Solution HUMAN PRESCRIPTION DRUG 07/01/2005 01/01/1900 Molybdenum Mo-99 NDA NDA017243 19 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 11 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 14 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 16 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 19 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 7.5 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 5 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 6 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 1 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 1.5 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 2 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 2.5 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 3 Ci/1
Ultra-Technekow Technetium Tc-99m Injection, Solution HUMAN PRESCRIPTION DRUG 06/10/2014 01/01/1900 Technetium Tc-99m Sodium Pertechnetate NDA NDA017243 3.5 Ci/1
UltraTag Kit for the preparation of Technetium Tc 99m-Labeled Red Blood Cells Kit HUMAN PRESCRIPTION DRUG 06/10/1991 01/01/1900 NDA NDA019981
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA050608 1; .5 g/1; g/1
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA050608 2; 1 g/1; g/1
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA050608 1; .5 g/1; g/1
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA050608 2; 1 g/1; g/1
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA050608 100; 50 mg/mL; mg/mL
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA062901 1; .5 g/1; g/1
UNASYN ampicillin sodium and sulbactam sodium Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 11/22/1991 01/01/1900 Ampicillin Sodium; Sulbactam Sodium NDA NDA062901 2; 1 g/1; g/1
URELLE hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, Tablet HUMAN PRESCRIPTION DRUG 01/12/2015 01/01/1900 Hyoscyamine Sulfate; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Phosphate, Mon UNAPPROVED DRUG OTHER .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1
Uroxatral alfuzosin hydrochloride Tablet, Extended Release HUMAN PRESCRIPTION DRUG 06/05/2009 01/01/1900 Alfuzosin Hydrochloride NDA NDA021287 10 mg/1
Valcyte valganciclovir hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/29/2001 01/01/1900 Valganciclovir Hydrochloride NDA NDA021304 450 mg/1
Valcyte valganciclovir hydrochloride Powder, For Solution HUMAN PRESCRIPTION DRUG 08/28/2009 01/01/1900 Valganciclovir Hydrochloride NDA NDA022257 50 mg/mL
VANIQA eflornithine hydrochloride Cream HUMAN PRESCRIPTION DRUG 06/01/2013 01/01/1900 Eflornithine Hydrochloride NDA NDA021145 139 mg/g
VAQTA hepatitis A vaccine, inactivated Injection, Suspension VACCINE 03/29/1996 01/01/1900 Hepatitis A Virus Strain Cr 326f Antigen (formaldehyde Inactivated) BLA BLA103606 50 [iU]/mL
VAQTA hepatitis A vaccine, inactivated Injection, Suspension VACCINE 03/29/1996 01/01/1900 Hepatitis A Virus Strain Cr 326f Antigen (formaldehyde Inactivated) BLA BLA103606 25 [iU]/.5mL
VAQTA hepatitis A vaccine, inactivated Injection, Suspension VACCINE 03/29/1996 01/01/1900 Hepatitis A Virus Strain Cr 326f Antigen (formaldehyde Inactivated) BLA BLA103606 25 [iU]/.5mL
VAQTA hepatitis A vaccine, inactivated Injection, Suspension VACCINE 03/29/1996 01/01/1900 Hepatitis A Virus Strain Cr 326f Antigen (formaldehyde Inactivated) BLA BLA103606 50 [iU]/mL
VARIVAX Varicella Virus Vaccine Live Injection, Powder, Lyophilized, For Suspension VACCINE 03/17/1995 01/01/1900 Varicella-zoster Virus Strain Oka/merck Live Antigen BLA BLA103552 1350 [PFU]/.5mL
VARIVAX Varicella Virus Vaccine Live Injection, Powder, Lyophilized, For Suspension VACCINE 03/17/1995 01/01/1900 Varicella-zoster Virus Strain Oka/merck Live Antigen BLA BLA103552 1350 [PFU]/.5mL
VFEND voriconazole Powder, For Suspension HUMAN PRESCRIPTION DRUG 03/28/2003 01/01/1900 Voriconazole NDA NDA021630 40 mg/mL
VFEND voriconazole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/28/2003 01/01/1900 Voriconazole NDA NDA021266 50 mg/1
VFEND voriconazole Tablet, Film Coated HUMAN PRESCRIPTION DRUG 03/28/2003 01/01/1900 Voriconazole NDA NDA021266 200 mg/1
VFEND VORICONAZOLE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 10/24/2012 01/01/1900 Voriconazole NDA NDA021267 10 mg/mL
VFEND VORICONAZOLE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 05/24/2002 01/01/1900 Voriconazole NDA NDA021267 10 mg/mL
VFEND voriconazole Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 03/28/2003 01/01/1900 Voriconazole NDA NDA021267 10 mg/mL
VFEND VORICONAZOLE Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 10/24/2012 01/01/1900 Voriconazole NDA NDA021267 10 mg/mL
vinorelbine tartrate vinorelbine tartrate Injection, Solution HUMAN PRESCRIPTION DRUG 02/13/2008 01/01/1900 Vinorelbine Tartrate ANDA ANDA178408 10 mg/mL
Vistaril hydroxyzine hydrochloride Solution HUMAN PRESCRIPTION DRUG 09/18/1957 01/01/1900 Hydroxyzine Hydrochloride NDA NDA011111 50 mg/mL
Vivaglobin Human Immunoglobulin G Solution HUMAN PRESCRIPTION DRUG 01/09/2006 01/01/1900 Human Immunoglobulin G BLA BLA125115 160 mg/mL
VIVITE Aftercare Environmental Protection Sunscreen SPF 30 octinoxate, octisalate, zinc oxide Cream HUMAN OTC DRUG 10/15/2011 06/30/2015 Octinoxate; Octisalate; Zinc Oxide OTC MONOGRAPH NOT FINAL part352 75; 40; 78 mg/g; mg/g; mg/g
VIVITE Daily Facial Moisturizer with Sunscreen SPF 30 octinoxate, octisalate, oxybenzone Lotion HUMAN OTC DRUG 05/19/2008 01/01/1900 Octinoxate; Octisalate; Oxybenzone OTC MONOGRAPH NOT FINAL part352 75; 50; 60 mg/mL; mg/mL; mg/mL
VUMON TENIPOSIDE Injection, Solution HUMAN PRESCRIPTION DRUG 07/14/1992 07/14/2015 Teniposide NDA NDA020119 10 mg/mL
Xalatan latanoprost Solution HUMAN PRESCRIPTION DRUG 03/20/1995 01/01/1900 Latanoprost NDA NDA020597 50 ug/mL
Xanax alprazolam Tablet HUMAN PRESCRIPTION DRUG 10/16/1981 01/01/1900 Alprazolam NDA NDA018276 0.25 mg/1
Xanax alprazolam Tablet HUMAN PRESCRIPTION DRUG 10/16/1981 01/01/1900 Alprazolam NDA NDA018276 0.5 mg/1
Xanax alprazolam Tablet, Extended Release HUMAN PRESCRIPTION DRUG 01/17/2003 01/01/1900 Alprazolam NDA NDA021434 0.5 mg/1
Xanax alprazolam Tablet, Extended Release HUMAN PRESCRIPTION DRUG 01/17/2003 01/01/1900 Alprazolam NDA NDA021434 1 mg/1
Xanax alprazolam Tablet, Extended Release HUMAN PRESCRIPTION DRUG 01/17/2003 01/01/1900 Alprazolam NDA NDA021434 2 mg/1
Xanax alprazolam Tablet, Extended Release HUMAN PRESCRIPTION DRUG 01/17/2003 01/01/1900 Alprazolam NDA NDA021434 3 mg/1
Xanax alprazolam Tablet HUMAN PRESCRIPTION DRUG 10/16/1981 01/01/1900 Alprazolam NDA NDA018276 1 mg/1
Xanax alprazolam Tablet HUMAN PRESCRIPTION DRUG 10/16/1981 01/01/1900 Alprazolam NDA NDA018276 2 mg/1
Xeloda capecitabine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/30/1998 01/01/1900 Capecitabine NDA NDA020896 150 mg/1
Xeloda capecitabine Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/30/1998 01/01/1900 Capecitabine NDA NDA020896 500 mg/1
Xenical orlistat Capsule HUMAN PRESCRIPTION DRUG 12/17/2010 01/01/1900 Orlistat NDA NDA020766 120 mg/1
Xyzal levocetirizine dihydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 08/09/2007 01/01/1900 Levocetirizine Dihydrochloride NDA NDA022064 5 mg/1
Xyzal levocetirizine dihydrochloride Solution HUMAN PRESCRIPTION DRUG 04/02/2008 01/01/1900 Levocetirizine Dihydrochloride NDA NDA022157 0.5 mg/mL
YERVOY ipilimumab Injection HUMAN PRESCRIPTION DRUG 03/25/2011 01/01/1900 Ipilimumab BLA BLA125377 5 mg/mL
YERVOY ipilimumab Injection HUMAN PRESCRIPTION DRUG 03/25/2011 01/01/1900 Ipilimumab BLA BLA125377 5 mg/mL
Zaleplon Zaleplon Capsule HUMAN PRESCRIPTION DRUG 06/06/2008 01/01/1900 Zaleplon ANDA ANDA077237 5 mg/1
Zaleplon Zaleplon Capsule HUMAN PRESCRIPTION DRUG 06/06/2008 01/01/1900 Zaleplon ANDA ANDA077237 10 mg/1
ZALTRAP ziv-aflibercept Solution, Concentrate HUMAN PRESCRIPTION DRUG 08/03/2012 01/01/1900 Aflibercept BLA BLA125418 100 mg/4mL
ZALTRAP ziv-aflibercept Solution, Concentrate HUMAN PRESCRIPTION DRUG 08/03/2012 01/01/1900 Aflibercept BLA BLA125418 200 mg/8mL
Zemaira alpha-1-proteinase inhibitor human Kit PLASMA DERIVATIVE 07/08/2003 01/01/1900 BLA BLA125078
Zemuron rocuronium bromide Injection, Solution HUMAN PRESCRIPTION DRUG 03/17/1994 01/01/1900 Rocuronium Bromide NDA NDA020214 10 mg/mL
ZERIT Stavudine Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/1994 01/01/1900 Stavudine NDA NDA020412 15 mg/1
ZERIT stavudine Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/1994 01/01/1900 Stavudine NDA NDA020412 20 mg/1
ZERIT stavudine Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/1994 01/01/1900 Stavudine NDA NDA020412 30 mg/1
ZERIT stavudine Capsule, Gelatin Coated HUMAN PRESCRIPTION DRUG 06/24/1994 01/01/1900 Stavudine NDA NDA020412 40 mg/1
ZERIT stavudine Powder, For Solution HUMAN PRESCRIPTION DRUG 09/06/1996 01/01/1900 Stavudine NDA NDA020413 1 mg/mL
Zidovudine Zidovudine Tablet HUMAN PRESCRIPTION DRUG 09/19/2005 01/01/1900 Zidovudine ANDA ANDA076844 300 mg/1
Zinecard dexrazoxane Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 05/26/1995 01/01/1900 Dexrazoxane Hydrochloride NDA NDA020212 250 mg/25mL
Zinecard dexrazoxane Injection, Powder, Lyophilized, For Solution HUMAN PRESCRIPTION DRUG 05/26/1995 01/01/1900 Dexrazoxane Hydrochloride NDA NDA020212 500 mg/50mL
ZIOPTAN TAFLUPROST Solution HUMAN PRESCRIPTION DRUG 02/10/2012 01/01/1900 Tafluprost NDA NDA202514 0.0045 mg/.3mL
ZOCOR SIMVASTATIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/23/1991 01/01/1900 Simvastatin NDA NDA019766 40 mg/1
ZOCOR SIMVASTATIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/23/1991 01/01/1900 Simvastatin NDA NDA019766 10 mg/1
ZOCOR SIMVASTATIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/23/1991 01/01/1900 Simvastatin NDA NDA019766 20 mg/1
ZOCOR SIMVASTATIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/23/1991 01/01/1900 Simvastatin NDA NDA019766 5 mg/1
ZOCOR SIMVASTATIN Tablet, Film Coated HUMAN PRESCRIPTION DRUG 12/23/1991 01/01/1900 Simvastatin NDA NDA019766 80 mg/1
ZOLINZA vorinostat Capsule HUMAN PRESCRIPTION DRUG 10/06/2006 01/01/1900 Vorinostat NDA NDA021991 100 mg/1
Zoloft sertraline hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 02/11/1992 01/01/1900 Sertraline Hydrochloride NDA NDA019839 50 mg/1
Zoloft sertraline hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 02/11/1992 01/01/1900 Sertraline Hydrochloride NDA NDA019839 100 mg/1
Zoloft sertraline hydrochloride Solution, Concentrate HUMAN PRESCRIPTION DRUG 02/11/1992 01/01/1900 Sertraline Hydrochloride NDA NDA020990 20 mg/mL
Zoloft sertraline hydrochloride Tablet, Film Coated HUMAN PRESCRIPTION DRUG 02/11/1992 01/01/1900 Sertraline Hydrochloride NDA NDA019839 25 mg/1
Zolpidem Tartrate zolpidem tartrate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/27/2007 01/01/1900 Zolpidem Tartrate ANDA ANDA077214 5 mg/1
Zolpidem Tartrate zolpidem tartrate Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/27/2007 01/01/1900 Zolpidem Tartrate ANDA ANDA077214 10 mg/1
ZONTIVITY vorapaxar Tablet, Film Coated HUMAN PRESCRIPTION DRUG 05/08/2014 01/01/1900 Vorapaxar Sulfate NDA NDA204886 2.08 mg/1
ZOSTAVAX Zoster Vaccine Live Injection, Powder, Lyophilized, For Suspension VACCINE 05/25/2006 01/01/1900 Varicella-zoster Virus Strain Oka/merck Live Antigen BLA BLA125123 19400 [PFU]/.65mL
ZYMAXID gatifloxacin Solution/ Drops HUMAN PRESCRIPTION DRUG 05/19/2010 01/01/1900 Gatifloxacin NDA NDA022548 5 mg/mL
Zyprexa Olanzapine Tablet HUMAN PRESCRIPTION DRUG 01/10/2000 01/01/1900 Olanzapine NDA NDA020592 15 mg/1
Zyprexa Olanzapine Tablet HUMAN PRESCRIPTION DRUG 03/01/2001 01/01/1900 Olanzapine NDA NDA020592 20 mg/1
ZYPREXA Olanzapine Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 06/01/2000 01/01/1900 Olanzapine NDA NDA021086 5 mg/1
ZYPREXA Olanzapine Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 06/01/2000 01/01/1900 Olanzapine NDA NDA021086 10 mg/1
ZYPREXA Olanzapine Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 09/01/2001 01/01/1900 Olanzapine NDA NDA021086 15 mg/1
ZYPREXA Olanzapine Tablet, Orally Disintegrating HUMAN PRESCRIPTION DRUG 09/01/2001 01/01/1900 Olanzapine NDA NDA021086 20 mg/1
Zyprexa Olanzapine Tablet HUMAN PRESCRIPTION DRUG 06/23/1997 01/01/1900 Olanzapine NDA NDA020592 2.5 mg/1
Zyprexa Olanzapine Tablet HUMAN PRESCRIPTION DRUG 10/01/1996 01/01/1900 Olanzapine NDA NDA020592 5 mg/1
Zyprexa Olanzapine Tablet HUMAN PRESCRIPTION DRUG 10/01/1996 01/01/1900 Olanzapine NDA NDA020592 7.5 mg/1
Zyprexa Olanzapine Tablet HUMAN PRESCRIPTION DRUG 10/01/1996 01/01/1900 Olanzapine NDA NDA020592 10 mg/1
ZYPREXA Olanzapine Injection, Powder, For Solution HUMAN PRESCRIPTION DRUG 04/01/2004 01/01/1900 Olanzapine NDA NDA021253 10 mg/2mL
ZYPREXA Olanzapine pamoate Kit HUMAN PRESCRIPTION DRUG 03/01/2010 01/01/1900 NDA NDA022173
ZYPREXA Olanzapine pamoate Kit HUMAN PRESCRIPTION DRUG 03/01/2010 01/01/1900 NDA NDA022173
ZYPREXA Olanzapine pamoate Kit HUMAN PRESCRIPTION DRUG 03/01/2010 01/01/1900 NDA NDA022173
Zyvox linezolid Tablet, Film Coated HUMAN PRESCRIPTION DRUG 04/18/2000 01/01/1900 Linezolid NDA NDA021130 600 mg/1
Zyvox linezolid Suspension HUMAN PRESCRIPTION DRUG 04/18/2000 01/01/1900 Linezolid NDA NDA021132 100 mg/5mL
Zyvox linezolid Injection, Solution HUMAN PRESCRIPTION DRUG 04/18/2000 01/01/1900 Linezolid NDA NDA021131 200 mg/100mL
Zyvox linezolid Injection, Solution HUMAN PRESCRIPTION DRUG 04/18/2000 01/01/1900 Linezolid NDA NDA021131 400 mg/200mL
Zyvox linezolid Injection, Solution HUMAN PRESCRIPTION DRUG 04/18/2000 01/01/1900 Linezolid NDA NDA021131 600 mg/300mL
Zyvox linezolid Injection, Solution HUMAN PRESCRIPTION DRUG 06/01/2015 01/01/1900 Linezolid NDA NDA021131 600 mg/300mL

Notes

  • Last updated on June 30, 2015