| Product |
Company |
Generic name |
KEGG DRUG |
Betamethasone Valerate ointment 1 mg/g (NDA)
Betamethasone Valerate lotion 1 mg/mL (NDA)
Betamethasone Valerate cream 1 mg/g (NDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
betamethasone valerate |
D01357
|
DARIFENACIN tablet, extended release 7.5 mg (ANDA)
DARIFENACIN tablet, extended release 15 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
DARIFENACIN |
D01699
|
|
Clobetasol Propionate (emollient) cream .5 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
clobetasol propionate |
D01272
|
Quinapril and Hydrochlorothiazide 10/12.5 tablet 12.5 mg (ANDA)
Quinapril and Hydrochlorothiazide 20/12.5 tablet 12.5 mg (ANDA)
Quinapril and Hydrochlorothiazide 20/25 tablet 25 mg (ANDA)
|
Cipla USA Inc. |
quinapril and Hydrochlorothiazide 10/12.5 |
D10278
|
Doxazosin tablet 8 mg (ANDA)
Doxazosin tablet 4 mg (ANDA)
Doxazosin tablet 2 mg (ANDA)
Doxazosin tablet 1 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Doxazosin Mesylate |
D00608
|
|
ENTACAPONE tablet, film coated 200 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
ENTACAPONE |
D00781
|
Neostigmine Methylsulfate injection .5 mg/mL (ANDA)
Neostigmine Methylsulfate injection 1 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Neostigmine Methylsulfate |
D00998
|
|
Aminocaproic Acid injection, solution 250 mg/mL (ANDA)
|
American Regent, Inc. |
Aminocaproic Acid |
D00160
|
Simvastatin tablet, film coated 20 mg (ANDA)
Simvastatin tablet, film coated 40 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Simvastatin |
D00434
|
Glipizide and Metformin Hydrochloride tablet, film coated 2.5 mg (ANDA)
Glipizide and Metformin Hydrochloride tablet, film coated 5 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Glipizide and Metformin Hydrochloride |
D10265
|
Thiotepa injection, powder, lyophilized, for solution 15 mg (ANDA)
Thiotepa injection, powder, lyophilized, for solution 100 mg (ANDA)
|
Gland Pharma Limited |
Thiotepa |
D00583
|
|
Tizanidine tablet 2 mg (ANDA)
|
Bryant Ranch Prepack |
Tizanidine |
D00776
|
|
Montelukast Sodium tablet, film coated 10 mg (ANDA)
|
Accord Healthcare Inc. |
Montelukast Sodium |
D00529
|
|
Sumatriptan injection 6 mg/.5mL (ANDA)
|
Xellia Pharmaceuticals USA LLC |
SUMATRIPTAN SUCCINATE |
D00676
|
|
Warfarin Sodium tablet 3 mg (ANDA)
|
Bryant Ranch Prepack |
warfarin sodium |
D00564
|
|
Magnesium Sulfate injection, solution 500 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
MAGNESIUM SULFATE HEPTAHYDRATE |
D01108
|
|
ELIQUIS tablet, film coated 2.5 mg (NDA)
|
Bryant Ranch Prepack |
apixaban |
D03213
|
|
ETHOSUXIMIDE capsule 250 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
ETHOSUXIMIDE |
D00539
|
Methylphenidate Hydrochloride solution 5 mg/5mL (ANDA)
Methylphenidate Hydrochloride solution 10 mg/5mL (ANDA)
|
Ascend Laboratories, LLC |
Methylphenidate Hydrochloride |
D01296
|
Doxepin Hydrochloride capsule 10 mg (ANDA)
Doxepin Hydrochloride capsule 25 mg (ANDA)
Doxepin Hydrochloride capsule 50 mg (ANDA)
Doxepin Hydrochloride capsule 75 mg (ANDA)
Doxepin Hydrochloride capsule 100 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Doxepin Hydrochloride |
D00814
|
|
Lessina kit (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Levonorgestrel and Ethinyl Estradiol |
D04482
|
|
Ketorolac Tromethamine solution/ drops 5 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
Ketorolac Tromethamine |
D00813
|
Tindamax tablet, film coated 250 mg (NDA)
Tindamax tablet, film coated 500 mg (NDA)
|
Mission Pharmacal Company |
tinidazole |
D01426
|
|
Apri 28 Day kit (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Desogestrel and Ethinyl Estradiol |
D04484
|
Ranolazine tablet, film coated, extended release 500 mg (ANDA)
Ranolazine tablet, film coated, extended release 1000 mg (ANDA)
|
Lifestar Pharma LLC |
Ranolazine |
D05700
|
|
AZITHROMYCIN tablet, film coated 600 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
AZITHROMYCIN |
D02134
|
|
Glycopyrrolate injection, solution .2 mg/mL (ANDA)
|
AuroMedics Pharma LLC |
Glycopyrrolate |
D00540
|
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 5 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 10 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 15 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 20 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 25 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 30 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 35 mg (ANDA)
DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release 40 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
dexmethylphenidate hydrochloride |
D03721
|
|
Niacor tablet 500 mg (ANDA)
|
Avondale Pharmaceuticals, LLC |
Niacin |
D00049
|
OSELTAMIVIR capsule 30 mg (ANDA)
OSELTAMIVIR capsule 45 mg (ANDA)
OSELTAMIVIR capsule 75 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
OSELTAMIVIR |
D00900
|
IRBESARTAN tablet 75 mg (ANDA)
IRBESARTAN tablet 150 mg (ANDA)
IRBESARTAN tablet 300 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
IRBESARTAN |
D00523
|
Budesonide suspension .25 mg/2mL (ANDA)
Budesonide suspension .5 mg/2mL (ANDA)
Budesonide suspension 1 mg/2mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Budesonide |
D00246
|
Cinacalcet tablet, film coated 30 mg (ANDA)
Cinacalcet tablet, film coated 60 mg (ANDA)
Cinacalcet tablet, film coated 90 mg (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Cinacalcet |
D03505
|
|
Lidocaine Hydrochloride solution 40 mg/mL (ANDA)
|
International Medication Systems, Limited |
Lidocaine Hydrochloride |
D02086
|
|
Bexarotene capsule, liquid filled 75 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
Bexarotene |
D03106
|
|
Lisinopril tablet 5 mg (ANDA)
|
Proficient Rx LP |
Lisinopril |
D00362
|
|
Levetiracetam injection, solution, concentrate 100 mg/mL (ANDA)
|
TAGI Pharma, Inc. |
levetiracetam |
D00709
|
|
Pyrimethamine tablet 25 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Pyrimethamine |
D00488
|
|
Sodium Bicarbonate injection 84 mg/mL (ANDA)
|
International Medication Systems, Limited |
Sodium Bicarbonate |
D01203
|
FAMOTIDINE tablet, film coated 20 mg (ANDA)
FAMOTIDINE tablet, film coated 40 mg (ANDA)
|
XLCare Pharmaceuticals, Inc. |
Famotidine |
D00318
|