| Product |
Company |
Generic name |
KEGG DRUG |
|
Azithromycin tablet, film coated 250 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Azithromycin |
D02134
|
|
Fluocinonide solution .5 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Fluocinonide |
D00325
|
|
Mycophenolate mofetil tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Mycophenolate mofetil |
D00752
|
|
Rylaze injection 20 mg/mL (BLA)
|
Jazz Pharmaceuticals, Inc. |
asparaginase erwinia chrysanthemi (recombinant)-rywn |
D02997
|
|
Ammonium Lactate lotion 120 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Ammonium Lactate |
D02920
|
|
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
|
|
CYCLOPHOSPHAMIDE injection, solution 200 mg/mL (NDA)
|
Dr. Reddy's Labratories Inc. |
cyclophosphamide |
D00287
|
|
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
|
|
Testosterone Cypionate injection, solution 200 mg/mL (ANDA)
|
Cipla USA Inc. |
Testosterone Cypionate |
D00957
|
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
|
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
|
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
|
|
SLYND kit (NDA)
|
Exeltis USA, Inc. |
Drospirenone |
D03917
|
Glipizide tablet 5 mg (ANDA)
Glipizide tablet 10 mg (ANDA)
|
Apotex Corp. |
Glipizide |
D00335
|
|
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
|
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
|
|
sirolimus tablet, film coated .5 mg (ANDA)
|
REMEDYREPACK INC. |
sirolimus |
D00753
|
|
NOREPINEPHRINE BITARTRATE injection, solution, concentrate 1 mg/mL (ANDA)
|
BIOCON PHARMA INC. |
NOREPINEPHRINE BITARTRATE |
D05206
|
Promethazine Hydrochloride injection 25 mg/mL (ANDA)
Promethazine Hydrochloride injection 50 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Promethazine Hydrochloride |
D00480
|
Lubiprostone capsule .008 mg (ANDA)
Lubiprostone capsule .024 mg (ANDA)
|
Northstar Rx LLC |
lubiprostone |
D04790
|
Olmesartan Medoxomil tablet, coated 5 mg (ANDA)
Olmesartan Medoxomil tablet, coated 20 mg (ANDA)
Olmesartan Medoxomil tablet, coated 40 mg (ANDA)
|
Modavar Pharmaceuticals LLC |
Olmesartan Medoxomil |
D01204
|
Fenofibrate tablet 48 mg (ANDA)
Fenofibrate tablet 145 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Fenofibrate |
D00565
|
|
hydroxyzine pamoate capsule 25 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
hydroxyzine pamoate |
D01096
|
|
Pyridostigmine Bromide tablet 60 mg (ANDA)
|
American Health Packaging |
Pyridostigmine Bromide |
D00487
|
|
Valproic Acid capsule, liquid filled 250 mg (ANDA)
|
ATLANTIC BIOLOGICALS CORP. |
Valproic Acid |
D00399
|
Gralise tablet, film coated 300 mg (NDA)
Gralise tablet, film coated 600 mg (NDA)
Gralise tablet, film coated 450 mg (NDA)
Gralise tablet, film coated 750 mg (NDA)
Gralise tablet, film coated 900 mg (NDA)
|
Almatica Pharma LLC |
gabapentin |
D00332
|