| Product |
Company |
Generic name |
KEGG DRUG |
Gabapentin capsule 100 mg (ANDA)
Gabapentin capsule 300 mg (ANDA)
Gabapentin capsule 400 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
Gabapentin
|
D00332
|
Alendronate Sodium tablet 10 mg (ANDA)
Alendronate Sodium tablet 35 mg (ANDA)
Alendronate Sodium tablet 70 mg (ANDA)
|
NorthStar Rx LLC
|
Alendronate Sodium
|
D00939
|
Gabapentin tablet 600 mg (ANDA)
Gabapentin tablet 800 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
Gabapentin
|
D00332
|
Kanjinti injection, powder, lyophilized, for solution 420 mg/20mL (BLA)
Kanjinti injection, powder, lyophilized, for solution 150 mg/7.15mL (BLA)
|
Amgen, Inc
|
trastuzumab-anns
|
D03257
|
|
Oxybutynin Chloride tablet 5 mg (ANDA)
|
Strides Pharma Science Limited
|
Oxybutynin Chloride
|
D00722
|
Zafirlukast tablet, coated 10 mg (NDA AUTHORIZED GENERIC)
Zafirlukast tablet, coated 20 mg (NDA AUTHORIZED GENERIC)
|
Strides Pharma Science Limited
|
zafirlukast
|
D00411
|
Methylphenidate Hydrochloride tablet, extended release 18 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 27 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 36 mg (ANDA)
Methylphenidate Hydrochloride tablet, extended release 54 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc.
|
Methylphenidate Hydrochloride
|
D01296
|
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, extended release 750 mg (ANDA)
|
MARKSANS PHARMA LIMITED
|
Metformin Hydrochloride
|
D00944
|
|
liraglutide injection, solution 6 mg/mL (ANDA)
|
Orbicular Pharmaceutical Technologies Private Limited
|
liraglutide
|
D06404
|
|
SUMATRIPTAN injection, solution 6 mg/.5mL (ANDA)
|
Strides Pharma Science Limited
|
sumatriptan
|
D00676
|
|
Zyprexa tablet, film coated 2.5 mg (NDA)
|
UNITAX-Pharmalogistik GmbH
|
OLANZAPINE
|
D00454
|
|
Halobetasol Propionate lotion .5 mg/g (NDA AUTHORIZED GENERIC)
|
Coral Way Pharma, LLC
|
Halobetasol propionate
|
D04409
|
|
OXYGEN gas 992 mL/L (NDA)
|
Airgas USA, LLC
|
OXYGEN
|
D00003
|
|
Eurax cream 100 mg/g (NDA)
|
Journey Medical Corporation
|
crotamiton
|
D01381
|
|
Nitrogen, Refrigerated liquid 992 mL/L (NDA)
|
Airgas Usa, LLC
|
Nitrogen, Refrigerated
|
D00083
|
Oxybutynin Chloride tablet 5 mg (ANDA)
Oxybutynin Chloride tablet 2.5 mg (ANDA)
|
Strides Pharma Science Limited
|
oxybutynin chloride
|
D00722
|
|
Ethyol injection 500 mg0mL (NDA)
|
Legacy Pharma USA Inc.
|
Amifostine
|
D00226
|
VYKOURA injection 50 mg/5mL (NDA)
VYKOURA injection 350 mg/35mL (NDA)
VYKOURA injection 500 mg/50mL (NDA)
|
Avyxa Pharma, LLC
|
leucovorin calcium
|
D01211
|
Carbidopa and Levodopa tablet, extended release 25 mg (ANDA)
Carbidopa and Levodopa tablet, extended release 50 mg (ANDA)
|
Safecor Health, LLC
|
carbidopa and levodopa
|
D00253
|
|
TOPIRAMATE solution 25 mg/mL (ANDA)
|
Ascend Laboratories, LLC
|
TOPIRAMATE
|
D00537
|
|
CARISOPRODOL tablet 350 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
CARISOPRODOL
|
D00768
|
|
Clozapine tablet, orally disintegrating 100 mg (ANDA)
|
Safecor Health, LLC
|
clozapine
|
D00283
|
|
Valsartan tablet, film coated 320 mg (ANDA)
|
A-S Medication Solutions
|
Valsartan
|
D00400
|
Benazepril Hydrochloride tablet, film coated 20 mg (ANDA)
Benazepril Hydrochloride tablet, film coated 40 mg (ANDA)
|
Aurobindo Pharma Limited
|
Benazepril Hydrochloride
|
D00620
|
|
MACI implant 15000000 1 (BLA)
|
Vericel Corporation
|
autologous cultured chondrocytes
|
|
|
rifampin capsule 300 mg (ANDA)
|
Bryant Ranch Prepack
|
rifampin
|
D00211
|
|
Sucralfate suspension 1 g0mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma
|
Sucralfate
|
D00446
|
|
ziprasidone hydrochloride capsule 80 mg (ANDA)
|
Bryant Ranch Prepack
|
ziprasidone hydrochloride
|
D01939
|
|
FOSAMAX tablet 70 mg (NDA)
|
Organon LLC
|
alendronate sodium
|
D00939
|
|
IZERVAY injection 20 mg/mL (NDA)
|
Astellas Pharma US, Inc.
|
avacincaptad pegol
|
D11748
|
|
Climara Pro patch .045 mg/d (NDA)
|
Bayer HealthCare Pharmaceuticals Inc.
|
Estradiol and Levonorgestrel
|
D09187
|
|
montelukast sodium tablet, chewable 5 mg (ANDA)
|
A-S Medication Solutions
|
montelukast sodium
|
D00529
|
Cyclophosphamide injection, powder, for solution 500 mg/25mL (ANDA)
Cyclophosphamide injection, powder, for solution 1 g/50mL (ANDA)
Cyclophosphamide injection, powder, for solution 2 g00mL (ANDA)
|
BluePoint Laboratories
|
cyclophosphamide
|
D00287
|
|
Metoprolol Tartrate injection, solution 5 mg/5mL (ANDA)
|
FOSUN PHARMA USA INC
|
Metoprolol Tartrate
|
D00601
|
Climara patch .025 mg/d (NDA)
Climara patch .0375 mg/d (NDA)
Climara patch .05 mg/d (NDA)
Climara patch .06 mg/d (NDA)
Climara patch .075 mg/d (NDA)
Climara patch .1 mg/d (NDA)
|
Bayer HealthCare Pharmaceuticals Inc.
|
Estradiol
|
D00105
|
|
Tembexa tablet, film coated 100 mg (NDA)
|
Emergent BioDefense Operations Lansing LLC
|
Brincidofovir
|
D10547
|
Topamax tablet, coated 25 mg (NDA)
Topamax tablet, coated 50 mg (NDA)
Topamax tablet, coated 100 mg (NDA)
Topamax tablet, coated 200 mg (NDA)
Topamax capsule, coated pellets 25 mg (NDA)
Topamax capsule, coated pellets 15 mg (NDA)
|
Janssen Pharmaceuticals, Inc.
|
topiramate
|
D00537
|
|
Sotalol tablet 80 mg (ANDA)
|
Bryant Ranch Prepack
|
Sotalol Hydrochloride
|
D01026
|
|
OLMESARTAN MEDOXOMIL tablet 40 mg (ANDA)
|
Bryant Ranch Prepack
|
olmesartan medoxomil
|
D01204
|
|
Lialda tablet, delayed release 1.2 g (NDA)
|
Takeda Pharmaceuticals America, Inc.
|
mesalamine
|
D00377
|