| Product |
Company |
Generic name |
KEGG DRUG |
Isturisa tablet, coated 1 mg (NDA)
Isturisa tablet, coated 5 mg (NDA)
|
Recordati Rare Diseases, Inc. |
osilodrostat |
D11062
|
|
Nitrogen gas 990 mL/L (NDA)
|
All Gas & Welding Supplies Co., Inc. |
Nitrogen |
D00083
|
|
Colchicine tablet, film coated .6 mg (ANDA)
|
REMEDYREPACK INC. |
Colchicine |
D00570
|
|
Fosfomycin tromethamine granule, for solution 3 g (ANDA)
|
Aurobindo Pharma Limited |
Fosfomycin tromethamine |
D00925
|
|
Cleocin cream 20 mg/g (NDA)
|
Pharmacia & Upjohn Company LLC |
clindamycin phosphate |
D01073
|
|
TRANEXAMIC ACID injection 100 mg/mL (ANDA)
|
Northstar Rx LLC |
Tranexamic acid |
D01136
|
Gilotrif tablet, film coated 30 mg (NDA)
Gilotrif tablet, film coated 40 mg (NDA)
Gilotrif tablet, film coated 20 mg (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
afatinib |
D09733
|
|
Tygacil injection, powder, lyophilized, for solution 50 mg/5mL (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
TIGECYCLINE |
D01079
|
|
Oxygen gas 990 mL/L (NDA)
|
Roberts Oxygen Company, Inc. |
Oxygen |
D00003
|
|
Levothyroxine Sodium tablet .137 mg (ANDA)
|
A-S Medication Solutions |
Levothyroxine Sodium |
D01010
|
|
Fluconazole tablet 150 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Fluconazole |
D00322
|
|
Phentermine Hydrochloride tablet 37.5 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Phentermine Hydrochloride |
D05459
|
SUMATRIPTAN SUCCINATE injection 4 mg/.5mL (ANDA)
SUMATRIPTAN SUCCINATE injection 6 mg/.5mL (ANDA)
|
Alembic Pharmaceuticals Inc. |
sumatriptan succinate |
D00676
|
Voriconazole tablet, film coated 50 mg (ANDA)
Voriconazole tablet, film coated 200 mg (ANDA)
|
Ajanta Pharma USA Inc. |
Voriconazole |
D00578
|
SUMATRIPTAN SUCCINATE injection 4 mg/.5mL (ANDA)
SUMATRIPTAN SUCCINATE injection 6 mg/.5mL (ANDA)
|
Alembic Pharmaceuticals Limited |
sumatriptan succinate |
D00676
|
|
Irbesartan and Hydrochlorothiazide tablet 12.5 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Irbesartan and Hydrochlorothiazide |
D10249
|
|
Rufinamide suspension 40 mg/mL (ANDA)
|
American Health Packaging |
Rufinamide |
D05775
|
Metolazone tablet 2.5 mg (ANDA)
Metolazone tablet 5 mg (ANDA)
Metolazone tablet 10 mg (ANDA)
|
Ingenus Pharmaceuticals LLC |
Metolazone |
D00431
|
ATORVASTATIN CALCIUM tablet, film coated 10 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 20 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 40 mg (ANDA)
ATORVASTATIN CALCIUM tablet, film coated 80 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
ATORVASTATIN CALCIUM |
D02258
|
|
mesalamine tablet, delayed release 1.2 g (ANDA)
|
Northstar Rx LLC. |
mesalamine |
D00377
|
Ondansetron tablet, orally disintegrating 4 mg (ANDA)
Ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
AvKARE |
Ondansetron |
D00678
|
|
Extended Phenytoin Sodium capsule 100 mg (ANDA)
|
REMEDYREPACK INC. |
Phenytoin Sodium |
D02103
|
|
DABIGATRAN capsule 150 mg (ANDA)
|
AvPAK |
DABIGATRAN ETEXILATE |
D07082
|
Medrol tablet 4 mg (NDA)
Medrol tablet 8 mg (NDA)
Medrol tablet 16 mg (NDA)
Medrol tablet 2 mg (NDA)
|
Pharmacia & Upjohn Company LLC |
methylprednisolone |
D00407
|
|
NALMEFENE HYDROCHLORIDE injection, solution 1 mg/mL (ANDA)
|
Purdue Pharma L.P. |
NALMEFENE HYDROCHLORIDE |
D02104
|
|
Trihexyphenidyl Hydrochloride tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
Trihexyphenidyl Hydrochloride |
D00787
|
|
Felodipine tablet, extended release 2.5 mg (ANDA)
|
Bryant Ranch Prepack |
Felodipine |
D00319
|
Enalapril maleate tablet 2.5 mg (ANDA)
Enalapril maleate tablet 5 mg (ANDA)
Enalapril maleate tablet 10 mg (ANDA)
Enalapril maleate tablet 20 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Enalapril maleate |
D00621
|
|
Azithromycin tablet, film coated 250 mg (ANDA)
|
REMEDYREPACK INC. |
Azithromycin |
D02134
|
Levothyroxine sodium tablet 25 ug (ANDA)
Levothyroxine sodium tablet 50 ug (ANDA)
Levothyroxine sodium tablet 75 ug (ANDA)
Levothyroxine sodium tablet 88 ug (ANDA)
Levothyroxine sodium tablet 100 ug (ANDA)
Levothyroxine sodium tablet 112 ug (ANDA)
Levothyroxine sodium tablet 125 ug (ANDA)
Levothyroxine sodium tablet 137 ug (ANDA)
Levothyroxine sodium tablet 150 ug (ANDA)
Levothyroxine sodium tablet 175 ug (ANDA)
Levothyroxine sodium tablet 200 ug (ANDA)
Levothyroxine sodium tablet 300 ug (ANDA)
|
Teva Pharmaceuticals, Inc. |
Levothyroxine sodium |
D01010
|
|
TEZSPIRE injection, solution 210 mg.9mL (BLA)
|
Amgen Inc |
tezepelumab-ekko |
D11771
|
Estradiol Valerate injection 10 mg/mL (ANDA)
Estradiol Valerate injection 20 mg/mL (ANDA)
Estradiol Valerate injection 40 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Estradiol Valerate |
D01413
|
|
Pramipexole Dihydrochloride tablet .75 mg (ANDA)
|
Bryant Ranch Prepack |
Pramipexole Dihydrochloride |
D00559
|
|
Doxycycline injection, powder, lyophilized, for solution 100 mg0mL (ANDA)
|
Northstar Rx LLC. |
Doxycycline |
D02129
|
|
Pravastatin Sodium tablet 40 mg (ANDA)
|
REMEDYREPACK INC. |
Pravastatin Sodium |
D00893
|
|
Ibuprofen tablet, film coated 800 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Ibuprofen |
D00126
|
|
Ibandronate Sodium tablet, film coated 150 mg (ANDA)
|
Aurobindo Pharma Limited |
Ibandronate Sodium |
D04486
|
Rivastigmine patch, extended release 4.6 mg/24h (ANDA)
Rivastigmine patch, extended release 9.5 mg/24h (ANDA)
Rivastigmine patch, extended release 13.3 mg/24h (ANDA)
|
Northstar Rx LLC. |
Rivastigmine |
D03822
|
Rivastigmine patch, extended release 4.6 mg/24h (ANDA)
Rivastigmine patch, extended release 9.5 mg/24h (ANDA)
Rivastigmine patch, extended release 13.3 mg/24h (ANDA)
|
Zydus Lifesciences Limited |
Rivastigmine |
D03822
|
|
OLANZAPINE injection, powder, lyophilized, for solution 10 mg (ANDA)
|
Eugia US LLC |
OLANZAPINE |
D00454
|