| Product |
Company |
Generic name |
KEGG DRUG |
|
Icatibant injection 30 mg/3mL (ANDA)
|
Alembic Pharmaceuticals Limited |
Icatibant |
D04492
|
|
Xyrem solution .5 g/mL (NDA)
|
Jazz Pharmaceuticals, Inc. |
sodium oxybate |
D05866
|
|
Ammonium Lactate cream 120 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Ammonium Lactate |
D02920
|
|
Dapsone gel 50 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Dapsone |
D00592
|
ROPINIROLE tablet, film coated .25 mg (ANDA)
ROPINIROLE tablet, film coated .5 mg (ANDA)
ROPINIROLE tablet, film coated 1 mg (ANDA)
ROPINIROLE tablet, film coated 2 mg (ANDA)
ROPINIROLE tablet, film coated 3 mg (ANDA)
ROPINIROLE tablet, film coated 4 mg (ANDA)
ROPINIROLE tablet, film coated 5 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
ROPINIROLE |
D00784
|
Amitriptyline Hydrochloride tablet, film coated 10 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 50 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 75 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 100 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 150 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Amitriptyline Hydrochloride |
D00809
|
Neostigmine Methylsulfate injection .5 mg/mL (ANDA)
Neostigmine Methylsulfate injection 1 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Neostigmine Methylsulfate |
D00998
|
Dilaudid injection, solution 1 mg/mL (NDA)
Dilaudid injection, solution 2 mg/mL (NDA)
Dilaudid injection, solution .2 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
Hydromorphone hydrochloride |
D00839
|
|
Sodium Chloride injection, solution 900 mg00mL (NDA)
|
Hospira, Inc. |
Sodium Chloride |
D02056
|
|
CYCLOPHOSPHAMIDE injection, solution 200 mg/mL (NDA)
|
Dr. Reddy's Labratories Inc. |
cyclophosphamide |
D00287
|
|
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
|
Actavis Pharma, Inc. |
bupropion hydrochloride |
D00817
|
|
Cephalexin capsule 250 mg (ANDA)
|
REMEDYREPACK INC. |
Cephalexin |
D00906
|
Dofetilide capsule .5 mg (ANDA)
Dofetilide capsule .25 mg (ANDA)
|
Mayne Pharma Inc. |
Dofetilide |
D00647
|
|
Streptomycin injection, powder, lyophilized, for solution 1 g (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
Streptomycin |
D01350
|
|
ZIIHERA injection, powder, lyophilized, for solution 50 mg/mL (BLA)
|
Jazz Pharmaceuticals, Inc. |
zanidatamab-hrii |
D12011
|
|
Icatibant injection 30 mg/3mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
Icatibant |
D04492
|
|
Lithium Carbonate capsule, gelatin coated 600 mg (NDA)
|
REMEDYREPACK INC. |
Lithium Carbonate |
D00801
|
|
Testosterone Cypionate injection, solution 200 mg/mL (ANDA)
|
Cipla USA Inc. |
Testosterone Cypionate |
D00957
|
|
Irbesartan tablet 300 mg (ANDA)
|
REMEDYREPACK INC. |
Irbesartan |
D00523
|
Carbatrol capsule, extended release 100 mg (NDA)
Carbatrol capsule, extended release 200 mg (NDA)
Carbatrol capsule, extended release 300 mg (NDA)
|
Takeda Pharmaceuticals America, Inc. |
carbamazepine |
D00252
|
|
Layolis Fe kit (NDA AUTHORIZED GENERIC)
|
Actavis Pharma, Inc. |
norethindrone, ethinyl estradiol, and ferrous fumarate |
D04483
|
XPHOZAH 10 mg tablet, film coated 10 mg (NDA)
XPHOZAH 20 mg tablet, film coated 20 mg (NDA)
XPHOZAH 30 mg tablet, film coated 30 mg (NDA)
|
Ardelyx, Inc. |
Tenapanor |
D11653
|
|
Sucralfate tablet 1 g (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Sucralfate |
D00446
|
|
Escitalopram solution 5 mg/5mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Escitalopram Oxalate |
D02567
|
Tacrolimus capsule .5 mg (ANDA)
Tacrolimus capsule 1 mg (ANDA)
Tacrolimus capsule 5 mg (ANDA)
|
Ajenat Pharmaceuticals LLC |
Tacrolimus |
D00107
|
Olmesartan Medoxomil and Hydrochlorothiazide tablet 12.5 mg (ANDA)
Olmesartan Medoxomil and Hydrochlorothiazide tablet 25 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Olmesartan Medoxomil and Hydrochlorothiazide |
D10284
|
|
leuprolide acetate kit (ANDA)
|
UBI Pharma Inc. |
leuprolide acetate |
D00989
|
|
SLYND kit (NDA)
|
Exeltis USA, Inc. |
Drospirenone |
D03917
|
Glipizide tablet 5 mg (ANDA)
Glipizide tablet 10 mg (ANDA)
|
Apotex Corp. |
Glipizide |
D00335
|
|
Levocetirizine Dihydrochloride tablet 5 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Levocetirizine Dihydrochloride |
D08118
|
Diclofenac Sodium and Misoprostol tablet, delayed release 50 mg (ANDA)
Diclofenac Sodium and Misoprostol tablet, delayed release 75 mg (ANDA)
|
Actavis Pharma, Inc. |
Diclofenac Sodium and Misoprostol |
D11091
|
|
Clonidine Hydrochloride tablet .2 mg (ANDA)
|
REMEDYREPACK INC. |
Clonidine Hydrochloride |
D00604
|
|
Ivabradine tablet, film coated 5 mg (ANDA)
|
American Health Packaging |
Ivabradine |
D08095
|
|
Baclofen tablet 20 mg (ANDA)
|
REMEDYREPACK INC. |
Baclofen |
D00241
|
Isoniazid tablet 100 mg (ANDA)
Isoniazid tablet 300 mg (ANDA)
|
Genus Lifesciences |
isoniazid |
D00346
|
|
Azathioprine tablet 50 mg (ANDA)
|
REMEDYREPACK INC. |
Azathioprine |
D00238
|
LOSARTAN POTASSIUM tablet, film coated 25 mg (ANDA)
LOSARTAN POTASSIUM tablet, film coated 50 mg (ANDA)
LOSARTAN POTASSIUM tablet, film coated 100 mg (ANDA)
|
Micro Labs Limited |
losartan potassium |
D00357
|
|
Kalbitor injection, solution 10 mg/mL (BLA)
|
Takeda Pharmaceuticals America, Inc. |
Ecallantide |
D03931
|
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
ATLANTIC BIOLOGICALS CORP. |
Sevelamer Carbonate |
D06642
|
Metformin Hydrochloride tablet, coated 500 mg (ANDA)
Metformin Hydrochloride tablet, coated 850 mg (ANDA)
Metformin Hydrochloride tablet, coated 1000 mg (ANDA)
|
Mullan Pharmaceutical Inc. |
Metformin Hydrochloride |
D00944
|