| 4/28/2023 |
NDA-019758 |
Clozaril (Clozapine) |
HERITAGE LIFE SCIENCES BARBADOS INC |
Archive |
| 9/20/2021 |
NDA-018936 |
Prozac (Fluoxetine Hydrochloride) |
ELI LILLY AND COMPANY |
Archive |
| 4/11/2019 |
NDA-022526 |
Addyi (Flibanserin) |
SPROUT PHARMACEUTICALS INC |
Archive |
| 3/09/2018 |
NDA-020839 |
Plavix (Clopidogrel Bisulfate) |
SANOFI AVENTIS US LLC |
Archive |
| 2/23/2017 |
ANDA-071212, ANDA-071173, ANDA-071172, ANDA-071157, ANDA-071156 |
Haloperidol |
FRONTIDA BIOPHANN INC |
Archive |
| 2/23/2017 |
ANDA-089903, ANDA-089523 |
Prochlorperazine Edisylate |
WEST-WARD PHARMACEUTICALS CORP |
Archive |
| 12/20/2016 |
ANDA-075523 |
Naloxone and Pentazocine |
SUN PHARMACEUTICAL INDUSTRIES, INC |
Archive |
| 12/16/2016 |
ANDA-081002 |
Meperidine Hydrochloride |
WEST-WARD PHARMACEUTICAL CORP |
Archive |
| 12/16/2016 |
ANDA-070765, ANDA-070766,
ANDA-070683 |
Amitriptyline Hydrochloride and Chlordiazepoxide,
Oxazepam |
FRONTIDA BIOPHARM INC |
Archive |
| 12/16/2016 |
ANDA-070444, ANDA-070445 |
Flurazepam Hydrochloride |
PAR PHARMACEUTICAL INC |
Archive |
| 12/16/2016 |
ANDA-075045, ANDA-075046 |
Butorphanol Tartrate |
WEST-WARD PHARMACEUTICALS CORP |
Archive |
| 12/16/2016 |
ANDA-205001 |
Acetaminophen and Hydrocodone Bitartrate |
PAR PHARMACEUTICAL, INC |
Archive |
| 12/16/2016 |
ANDA-089671, ANDA-089672 |
Acetaminophen and Codeine Phosphate |
FRONTIDA BIOPHARM INC |
Archive |
| 11/08/2016 |
ANDA-040805 |
Hydroxyzine Hydrochloride |
HETERO USA, INC
U.S. AGENT FOR HETERO LABS LIMITED UNIT- III |
Archive |
| 10/21/2016 |
ANDA-090387 |
Testosterone Cypionate |
WEST-WARD PHARMACEUTICAL CORP |
Archive |
| 10/21/2016 |
ANDA-091244 |
Testosterone Cypionate |
WEST-WARD PHARMACEUTICAL CORP |
Archive |
| 9/07/2016 |
NDA-022276 |
Nicardipine Hydrochloride |
EXELA PHARMA SCIENCES, LLC |
Archive |
| 5/09/2016 |
ANDA-070088 |
Ibuprofen |
BASF CORPORATION |
Archive |
| 5/09/2016 |
ANDA-074819,
ANDA-079093 |
Etodolac,
Nabumetone |
PROSAM LABS, LLC |
Archive |
| 12/15/2014 |
NDA-050824 |
Omeclamox-Pak (Omeprazole, Amoxicillin, and Clarithromycin) |
GASTROENTERO-LOGIC, LLC |
Archive |
| 9/18/2014 |
ANDA-078969 |
Granisetron Hydrochloride |
INC RESEARCH LLC |
Archive |
| 9/09/2014 |
ANDA-086498, ANDA-086499, ANDA-086500, ANDA-086501, ANDA-086502, ANDA-086503, ANDA-083827 |
Amitriptyline Hydrochloride,
Imipramine Hydrochloride |
ALRA LABORATORIES, INC |
Archive |
| 7/31/2014 |
NDA-009470 |
Xylocaine Viscous (Lidocaine Hydrochloride) |
FRESENIUS KABI USA LLC |
Archive |
| 7/22/2014 |
ANDA-076015 |
Fluoxetine Hydrochloride |
PHARMACEUTICAL ASSOCIATES, INC |
Archive |
| 7/22/2014 |
ANDA-040751, ANDA-040752, ANDA-040753 |
Imipramine Hydrochloride |
PROSAM LABS, LLC |
Archive |
| 7/22/2014 |
ANDA-075525 |
Fluoxetine Hydrochloride |
HI-TECH PHARMACAL CO., INC |
Archive |
| 7/22/2014 |
ANDA-071196,
ANDA-071258 |
Trazodone,
Trazodone Hydrochloride |
APOTEX INC |
Archive |
| 7/03/2014 |
NDA-014694 |
Hexadrol (Dexamethasone Sodium Phospate) |
ORGANON USA INC |
Archive |
| 6/03/2014 |
ANDA-088184, ANDA-088185 |
Hydroxyzine Hydrochloride |
FRESENIUS KABI USA, LLC |
Archive |
| 6/03/2014 |
ANDA-040600, ANDA-040602, ANDA-040604 |
Hydroxyzine Hydrochloride |
MIKAH PHARMA LLC |
Archive |
| 6/03/2014 |
ANDA-087014 |
Orgatrax (Hydroxyzine Hydrochloride) |
ORGANON USA INC |
Archive |
| 10/24/2013 |
ANDA-040261 |
Acetaminophen, Butalbital, and Caffeine |
WEST-WARD PHARMACEUTICALS CORP |
Archive |
| 10/24/2013 |
ANDA-087811 |
Phrenilin (Acetaminophen and Butalbital) |
KELLER AND HECKMAN LLP
U.S. AGENT FOR VALEANT INTERNATIONAL BERMUDA |
Archive |
| 10/24/2013 |
ANDA-040864 |
Acetaminophen, Butalbital, and Caffeine |
MIRROR PHARMACEUTICALS LLC |
Archive |
| 10/24/2013 |
ANDA-088831 |
Phrenilin Forte (Acetaminophen and Butalbital) |
KELLER AND HECKMAN LLP
U.S. AGENT FOR VALEANT INTERNATIONAL BERMUDA |
Archive |
| 10/24/2013 |
ANDA-040336 |
Acetaminophen, Butalbital, and Caffeine |
WEST-WARD PHARMACEUTICALS CORP |
Archive |
| 10/24/2013 |
ANDA-040688 |
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate |
WRASER PHARMACEUTICALS |
Archive |
| 10/24/2013 |
ANDA-040883 |
Acetaminophen, Butalbital, and Caffeine |
MIRROR PHARMACEUTICALS LLC |
Archive |
| 8/19/2013 |
ANDA-077417, ANDA-077809 |
Ciprofloxacin |
WATSON LABORATORIES, INC. - FLORIDA |
Archive |
| 8/19/2013 |
ANDA-078712 |
Ciprofloxacin |
SANDOZ, INC |
Archive |
| 5/10/2013 |
ANDA-088704 |
Triacin-C® Cough Syrup (Codeine Phosphate, Pseudoephedrine Hydrochloride, and Triprolidine Hydrochloride) |
CLINSMART LLC
U.S. AGENT FOR STI PHARMA LLC |
Archive |
| 5/10/2013 |
ANDA-087006 |
Acetaminophen and Codeine Phosphate |
WOCKHARDT EU OPERATIONS (SWISS) AG |
Archive |
| 5/10/2013 |
ANDA-040223 |
Acetaminophen and Codeine Phosphate |
BARR LABORATORIES, INC |
Archive |
| 5/10/2013 |
ANDA-040441 |
Acetaminophen and Codeine Phosphate |
WATSON LABORATORIES, INC - FLORIDA |
Archive |
| 5/10/2013 |
ANDA-040447, ANDA-040488 |
Acetaminophen and Codeine Phosphate |
WATSON LABORATORIES, INC - FLORIDA |
Archive |
| 5/10/2013 |
ANDA-089997, ANDA-089998, ANDA-089999 |
Acetaminophen and Codeine Phosphate |
WATSON LABORATORIES, INC |
Archive |
| 5/10/2013 |
ANDA-040688 |
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate |
WRASER PHARMACEUTICALS |
Archive |
| 5/10/2013 |
ANDA-040701 |
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate |
BOCA PHARMACAL, INC. |
Archive |
| 5/10/2013 |
ANDA-089671, ANDA-089672 |
Acetaminophen and Codeine Phosphate |
FRONTIDA BIOPHARM INC |
Archive |
| 5/10/2013 |
ANDA-040443 |
Acetaminophen and Codeine Phosphate |
WATSON LABORATORIES, INC - FLORIDA |
Archive |
| 4/11/2013 |
ANDA-073143, ANDA-074436 |
Cyclobenzaprine Hydrochloride |
WATSON LABORATORIES, INC |
Archive |
| 4/11/2013 |
ANDA-072854 |
Cyclobenzaprine Hydrochloride |
SANDOZ, INC |
Archive |
| 4/11/2013 |
ANDA-077209, ANDA-077291 |
Cyclobenzaprine Hydrochloride |
PROSAM LABS, LLC |
Archive |
| 12/20/2010 |
NDA-021358 |
MultiHance (Gadobenate Dimeglumine) and MultiHance Multipack (Gadobenate Dimeglumine) |
BRACCO DIAGNOSTICS, INC |
Archive |
| 11/02/2010 |
ANDA-074900, ANDA-074901 |
Atracurium Besylate |
BEDFORD LABORATORIES |
Archive |
| 11/02/2010 |
ANDA-074944,
ANDA-074945 |
Atracurium Besylate |
WATSON PHARMACEUTICALS, INC |
Archive |
| 11/02/2010 |
ANDA-090243 |
Vecuronium Bromide |
AKORN-STRIDES, LLC |
Archive |
| 11/02/2010 |
ANDA-078562 |
Mivacurium Chloride |
PISGAH LABS, INC |
Archive |
| 11/02/2010 |
ANDA-074334 |
Vecuronium |
WATSON PHARMACEUTICALS, INC |
Archive |
| 11/02/2010 |
ANDA-075218 |
Vecuronium Bromide |
BAXTER HEALTHCARE CORPORATION |
Archive |
| 6/02/2010 |
NDA-020692,
NDA-021077,
NDA-021254 |
Serevent Diskus (Salmeterol Xinafoate),
Advair Diskus (Fluticasone Propionate and Salmeterol), Advair HFA (Fluticasone Propionate and Salmeterol Xinafoate) |
GLAXOSMITHKLINE |
Archive |
| 6/02/2010 |
NDA-021929 |
Symbicort pMDI (Budesonide and Formoterol Fumarate) |
ASTRAZENECA LP |
Archive |
| 3/09/2010 |
NDA-019309 |
Vasotec (Enalapril Maleate) |
BIOVAIL LABORATORIES INTERNATIONAL SRL |
Archive |
| 1/21/2010 |
NDA-006188 |
Propylthiouracil |
DAVA PHARMACEUTICALS, INC |
Archive |
| 7/19/2009 |
NDA-020592, NDA-021253; NDA-021086 |
Zyprexa (Olanzapine), Zyprexa Zydis (Olanzapine) |
ELI LILLY AND COMPANY |
Archive |
| 7/19/2009 |
NDA-021520 |
Symbyax (Fluoxetine and Olanzapine) |
ELI LILLY AND COMPANY |
Archive |
| 7/30/2008 |
BLA-103234 |
Procrit (Epoetin Alfa) |
AMGEN, INCORPORATED |
Archive |
| 7/30/2008 |
BLA-103951 |
Aranesp (Darbepoetin Alpha) |
AMGEN, INCORPORATED |
Archive |
