| Product |
Company |
Generic name |
KEGG DRUG |
|
Rylaze injection 20 mg/mL (BLA)
|
Jazz Pharmaceuticals, Inc. |
asparaginase erwinia chrysanthemi (recombinant)-rywn |
D02997
|
|
Icatibant injection 30 mg/3mL (ANDA)
|
Alembic Pharmaceuticals Limited |
Icatibant |
D04492
|
|
Xyrem solution .5 g/mL (NDA)
|
Jazz Pharmaceuticals, Inc. |
sodium oxybate |
D05866
|
|
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
|
|
CYCLOPHOSPHAMIDE injection, solution 200 mg/mL (NDA)
|
Dr. Reddy's Labratories Inc. |
cyclophosphamide |
D00287
|
|
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
|
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 20 mg (ANDA)
Olmesartan Medoxomil and Hydrochlorothiazide tablet 40 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Olmesartan Medoxomil and Hydrochlorothiazide |
D10284
|
|
Ivabradine tablet, film coated 5 mg (ANDA)
|
American Health Packaging |
Ivabradine |
D08095
|
Isoniazid tablet 100 mg (ANDA)
Isoniazid tablet 300 mg (ANDA)
|
Genus Lifesciences |
isoniazid |
D00346
|
|
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
|
|
METFORMIN HYDROCHLORIDE tablet 1000 mg (ANDA)
|
A-S Medication Solutions |
METFORMIN HYDROCHLORIDE |
D00944
|
Vecuronium Bromide injection, powder, lyophilized, for solution 10 mg0mL (ANDA)
Vecuronium Bromide injection, powder, lyophilized, for solution 20 mg/20mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Vecuronium Bromide |
D00767
|
|
Pramosone Cream cream 10 mg/g (ANDA)
|
Legacy Pharma USA Inc. |
hydrocortisone acetate and pramoxine hydrochloride |
D11657
|
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 Inc. |
ROPINIROLE |
D00784
|
PHENERGAN injection 25 mg/mL (ANDA)
PHENERGAN injection 50 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Promethazine Hydrochloride |
D00480
|
|
bupropion Hydrochloride tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
bupropion Hydrochloride |
D00817
|
|
ZUSDURI kit (NDA)
|
UroGen Pharma, Inc |
Mitomycin |
D00208
|
Insulin glargine U-300 Max injection, solution 300 [iU]/mL (BLA)
Insulin glargine U-300 injection, solution 300 [iU]/mL (BLA)
|
Sanofi-Aventis U.S. LLC |
insulin glargine |
D03250
|
Pradaxa pellet 20 mg (NDA)
Pradaxa pellet 30 mg (NDA)
Pradaxa pellet 40 mg (NDA)
Pradaxa pellet 50 mg (NDA)
Pradaxa pellet 110 mg (NDA)
Pradaxa pellet 150 mg (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
dabigatran etexilate |
D07082
|
Eplerenone tablet 25 mg (ANDA)
Eplerenone tablet 50 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Eplerenone |
D01115
|
|
Imiquimod cream 37.5 mg/g (NDA AUTHORIZED GENERIC)
|
Teva Pharmaceuticals USA, Inc. |
imiquimod |
D02500
|
|
ICOSAPENT ETHYL capsule 1 g (ANDA)
|
Northstar Rx LLC |
Icosapent ethyl |
D01892
|
|
Doxycycline hyclate capsule 50 mg (ANDA)
|
Bryant Ranch Prepack |
Doxycycline hyclate |
D02129
|
|
Keppra injection, solution, concentrate 100 mg/mL (NDA)
|
UCB, Inc. |
levetiracetam |
D00709
|