| Product |
Company |
Generic name |
KEGG DRUG |
|
Digoxin tablet 250 ug (ANDA)
|
Bryant Ranch Prepack
|
Digoxin
|
D00298
|
|
Tretinoin capsule 10 mg (ANDA)
|
Major Pharmaceuticals
|
Tretinoin
|
D00094
|
|
CYCLOBENZAPRINE HYDROCHLORIDE tablet, film coated 5 mg (ANDA)
|
Bryant Ranch Prepack
|
cyclobenzaprine hydrochloride
|
D00772
|
|
Diazepam solution 5 mg/5mL (ANDA)
|
Major Pharmaceuticals
|
Diazepam
|
D00293
|
|
MACI implant 15000000 1 (BLA)
|
Vericel Corporation
|
autologous cultured chondrocytes
|
|
|
LURASIDONE HYDROCHLORIDE tablet 40 mg (ANDA)
|
REMEDYREPACK INC.
|
LURASIDONE HYDROCHLORIDE
|
D04820
|
|
Topiramate tablet, film coated 25 mg (ANDA)
|
REMEDYREPACK INC.
|
Topiramate
|
D00537
|
|
Amoxicillin capsule 500 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Amoxicillin
|
D00229
|
|
OXYCODONE AND ACETAMINOPHEN tablet 325 mg (ANDA)
|
Eywa Pharma Inc
|
oxycodone and acetaminophen
|
D02153
|
|
Arexvy kit (BLA)
|
GlaxoSmithKline Biologicals SA
|
Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted
|
D12607
|
|
Metformin tablet, extended release 500 mg (ANDA)
|
Bryant Ranch Prepack
|
Metformin ER 500 mg
|
D00944
|
|
Naproxen tablet 500 mg (ANDA)
|
Bryant Ranch Prepack
|
Naproxen
|
D00118
|
|
SULINDAC tablet 200 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
sulindac
|
D00120
|
|
Terazosin Hydrochloride capsule 1 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Terazosin Hydrochloride
|
D00610
|
|
Dexamethasone tablet 1.5 mg (ANDA)
|
Direct_rx
|
Dexamethasone
|
D00292
|
|
Ibuprofen tablet, film coated 600 mg (ANDA)
|
NuCare Pharmaceuticals, Inc.
|
Ibuprofen
|
D00126
|
|
Clonazepam tablet .5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Clonazepam
|
D00280
|
|
Cephalexin capsule 250 mg (ANDA)
|
NuCare Pharmaceuticals, Inc.
|
Cephalexin
|
D00906
|
|
Velphoro tablet, chewable 500 mg (NDA)
|
Fresenius Medical Care North America
|
sucroferric oxyhydroxide
|
D04616
|
|
Metformin Hydrochloride tablet, film coated 1000 mg (ANDA)
|
A-S Medication Solutions
|
Metformin Hydrochloride
|
D00944
|
clindamycin hydrochloride capsule 150 mg (NDA AUTHORIZED GENERIC)
clindamycin hydrochloride capsule 300 mg (NDA AUTHORIZED GENERIC)
|
Greenstone LLC
|
clindamycin hydrochloride
|
D02132
|
Losartan Potassium and Hydrochlorothiazide tablet, film coated 12.5 mg (ANDA)
Losartan Potassium and Hydrochlorothiazide tablet, film coated 25 mg (ANDA)
|
NorthStar Rx LLC
|
Losartan Potassium and Hydrochlorothiazide
|
D07895
|
Minocycline hydrochloride capsule 50 mg (ANDA)
Minocycline hydrochloride capsule 75 mg (ANDA)
Minocycline hydrochloride capsule 100 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc.
|
Minocycline hydrochloride
|
D00850
|
|
Carbamazepine capsule, extended release 200 mg (ANDA)
|
Major Pharmaceuticals
|
Carbamazepine
|
D00252
|
Naproxen tablet 250 mg (ANDA)
Naproxen tablet 375 mg (ANDA)
Naproxen tablet 500 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC
|
Naproxen
|
D00118
|
|
Ursodiol capsule 300 mg (ANDA)
|
Major Pharmaceuticals
|
Ursodiol
|
D00734
|
|
Nystatin suspension 100000 [USP'U]/mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma
|
NYSTATIN
|
D00202
|
|
Loxapine capsule 50 mg (ANDA)
|
REMEDYREPACK INC.
|
Loxapine
|
D00794
|
|
Gabapentin capsule 400 mg (ANDA)
|
Bryant Ranch Prepack
|
Gabapentin
|
D00332
|
Menveo kit (BLA)
Menveo injection, solution 10 ug/.5mL (BLA)
|
GlaxoSmithKline Biologicals SA
|
Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
|
D10535
|
|
Doxazosin tablet 2 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc.
|
Doxazosin
|
D00608
|
|
Testosterone Cypionate injection, solution 200 mg/mL (ANDA)
|
Bryant Ranch Prepack
|
Testosterone Cypionate
|
D00957
|
|
Fulvestrant injection, solution 50 mg/mL (ANDA)
|
Dr.Reddy's Laboratories Inc
|
Fulvestrant
|
D01161
|
Pregabalin capsule 25 mg (ANDA)
Pregabalin capsule 50 mg (ANDA)
Pregabalin capsule 75 mg (ANDA)
Pregabalin capsule 100 mg (ANDA)
Pregabalin capsule 150 mg (ANDA)
Pregabalin capsule 200 mg (ANDA)
Pregabalin capsule 225 mg (ANDA)
Pregabalin capsule 300 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC
|
Pregabalin
|
D02716
|
|
Omeprazole capsule, delayed release 40 mg (ANDA)
|
A-S Medication Solutions
|
Omeprazole
|
D00455
|
|
Cyclobenzaprine Hydrochloride capsule, extended release 30 mg (NDA AUTHORIZED GENERIC)
|
REMEDYREPACK INC.
|
Cyclobenzaprine Hydrochloride
|
D00772
|
Levothyroxine Sodium tablet .025 mg (ANDA)
Levothyroxine Sodium tablet .05 mg (ANDA)
Levothyroxine Sodium tablet .075 mg (ANDA)
Levothyroxine Sodium tablet .1 mg (ANDA)
Levothyroxine Sodium tablet .125 mg (ANDA)
Levothyroxine Sodium tablet .15 mg (ANDA)
Levothyroxine Sodium tablet .088 mg (ANDA)
|
Cardinal Health 107, LLC
|
Levothyroxine Sodium
|
D01010
|
Doxazosin tablet 1 mg (ANDA)
Doxazosin tablet 2 mg (ANDA)
Doxazosin tablet 4 mg (ANDA)
|
Major Pharmaceuticals
|
Doxazosin
|
D00608
|
|
Amiodarone Hydrochloride tablet 200 mg (ANDA)
|
Major Pharmaceuticals
|
Amiodarone Hydrochloride
|
D00636
|
|
Methocarbamol tablet, coated 750 mg (ANDA)
|
REMEDYREPACK INC.
|
Methocarbamol Tablets
|
D00402
|