| Product |
Company |
Generic name |
KEGG DRUG |
|
Simvastatin tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Simvastatin tablet, film coated 20 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
Diltiazem Hydrochloride tablet, film coated 30 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 60 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 90 mg (ANDA)
Diltiazem Hydrochloride tablet, film coated 120 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Diltiazem Hydrochloride |
D00616
|
|
Simvastatin tablet, film coated 40 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Betamethasone Dipropionate lotion, augmented .5 mg/mL (ANDA)
|
Encube Ethicals, Inc. |
BETAMETHASONE DIPROPIONATE |
D01637
|
|
Amoxicillin powder, for suspension 400 mg/5mL (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin |
D00229
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
|
Major Pharmaceuticals |
Metolazone |
D00431
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Irbesartan |
D00523
|
|
CALCITONIN SALMON injection, solution 200 [USP'U]/mL (ANDA)
|
Cipla USA Inc. |
CALCITONIN SALMON |
D00249
|
|
Simvastatin tablet, film coated 20 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
|
Sodium Bicarbonate injection, solution 84 mg/mL (ANDA)
|
Civica |
SODIUM BICARBONATE |
D01203
|
|
Simvastatin tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Simvastatin |
D00434
|
Dapsone tablet 25 mg (ANDA)
Dapsone tablet 100 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Dapsone |
D00592
|
Divalproex Sodium tablet, delayed release 250 mg (ANDA)
Divalproex Sodium tablet, delayed release 500 mg (ANDA)
|
Major Pharmaceuticals |
Divalproex Sodium |
D00304
|
|
Levetiracetam tablet, film coated 250 mg (ANDA)
|
A-S Medication Solutions |
Levetiracetam |
D00709
|
|
Leuprolide Acetate kit (ANDA)
|
NorthStar RxLLC |
Leuprolide Acetate |
D00989
|
Liomny tablet 5 ug (ANDA)
Liomny tablet 25 ug (ANDA)
Liomny tablet 50 ug (ANDA)
|
SIGMAPHARM LABORATORIES, LLC |
Liothyronine Sodium |
D01011
|
Dabigatran Etexilate capsule 75 mg (ANDA)
Dabigatran Etexilate capsule 150 mg (ANDA)
Dabigatran Etexilate capsule 110 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
Dabigatran Etexilate |
D07082
|
|
Oseltamivir phosphate capsule 45 mg (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED |
Oseltamivir phosphate |
D00900
|
|
OXYGEN gas 99 L00L (NDA)
|
Johnson Drug Company, Inc |
OXYGEN |
D00003
|
|
Mirtazapine tablet, film coated 15 mg (ANDA)
|
Bryant Ranch Prepack |
Mirtazapine |
D00563
|
|
Nitrogen gas 992 mL/L (NDA)
|
Victor Welding Supply Company |
Nitrogen |
D00083
|
ANTARA capsule 43 mg (NDA)
ANTARA capsule 130 mg (NDA)
|
Lupin Pharmaceuticals, Inc. |
FENOFIBRATE |
D00565
|
|
Nitrous Oxide gas 990 mL/L (NDA)
|
FULLERTON WELDING SUPPLY |
Nitrous Oxide |
D00102
|
|
Oxygen gas 990 mL/L (NDA)
|
FULLERTON WELDING SUPPLY |
Oxygen |
D00003
|
|
AHZANTIVE injection, solution 40 mg/mL (BLA)
|
Valorum Biologics, LLC |
aflibercept-mrbb |
D09574
|
Ropinirole tablet, extended release 2 mg (ANDA)
Ropinirole tablet, extended release 4 mg (ANDA)
Ropinirole tablet, extended release 6 mg (ANDA)
Ropinirole tablet, extended release 8 mg (ANDA)
Ropinirole tablet, extended release 12 mg (ANDA)
|
Elite Laboratories, Inc. |
Ropinirole |
D00784
|
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)
|
Marlex Pharmaceuticals Inc |
ropinirole |
D00784
|
Furosemide injection, solution 20 mg/2mL (ANDA)
Furosemide injection, solution 40 mg/4mL (ANDA)
Furosemide injection, solution 100 mg0mL (ANDA)
|
Eugia US LLC |
Furosemide |
D00331
|
|
Lidocaine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
ProPharma Distribution |
Lidocaine Hydrochloride |
D08127
|
|
Phenytoin Sodium injection 50 mg/mL (ANDA)
|
ProPharma Distribution |
Phenytoin Sodium |
D02103
|
|
Pantoprazole Sodium tablet, delayed release 20 mg (ANDA)
|
PHOENIX RX LLC |
Pantoprazole |
D02593
|
ampicillin sodium and sulbactam sodium injection, powder, for solution 1 g (ANDA)
ampicillin sodium and sulbactam sodium injection, powder, for solution 2 g (ANDA)
|
ONESOURCE SPECIALTY PHARMA LIMITED |
ampicillin sodium and sulbactam sodium |
D02065
|
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
|
Coupler LLC |
Carvedilol |
D00255
|
|
Cleocin T lotion 10 mg/mL (NDA)
|
Pharmacia & Upjohn Company LLC |
clindamycin phosphate |
D01073
|
ACETAZOLAMIDE tablet 125 mg (ANDA)
ACETAZOLAMIDE tablet 250 mg (ANDA)
|
Aurobindo Pharma Limited |
ACETAZOLAMIDE |
D00218
|
RIVAROXABAN kit (ANDA)
RIVAROXABAN tablet, film coated 10 mg (ANDA)
RIVAROXABAN tablet, film coated 15 mg (ANDA)
RIVAROXABAN tablet, film coated 20 mg (ANDA)
RIVAROXABAN tablet, film coated 2.5 mg (ANDA)
|
Alembic Pharmaceuticals Limited |
RIVAROXABAN |
D07086
|
|
TICAGRELOR tablet, film coated 90 mg (ANDA)
|
Solco Healthcare U.S., LLC |
ticagrelor |
D09017
|
Leflunomide tablet, film coated 10 mg (ANDA)
Leflunomide tablet, film coated 20 mg (ANDA)
|
Lupin Pharmaceuticals, Inc. |
Leflunomide |
D00749
|
|
Naltrexone Hydrochloride tablet, film coated 50 mg (ANDA)
|
TAGI Pharma Inc. |
Naltrexone Hydrochloride |
D02095
|