| Product |
Company |
Generic name |
KEGG DRUG |
|
Finasteride tablet, film coated 1 mg (ANDA)
|
Asclemed USA, Inc. |
Finasteride |
D00321
|
Tadalafil tablet, film coated 2.5 mg (ANDA)
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
Tadalafil tablet, film coated 20 mg (ANDA)
|
Qilu Pharmaceutical Co., Ltd. |
Tadalafil |
D02008
|
Ultramicrosize Griseofulvin tablet 125 mg (ANDA)
Ultramicrosize Griseofulvin tablet 250 mg (ANDA)
|
Sigmapharm Laboratories, LLC |
Ultramicrosize Griseofulvin |
D00209
|
Neostigmine Methylsulfate injection, solution .5 mg/mL (ANDA)
Neostigmine Methylsulfate injection, solution 1 mg/mL (ANDA)
|
Sagent Pharmaceuticals |
Neostigmine Methylsulfate |
D00998
|
|
Cytarabine injection, solution 20 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Cytarabine |
D00168
|
|
Eulexin capsule 125 mg (ANDA)
|
Waylis Therapeutics LLC |
Flutamide |
D00586
|
|
CROMOLYN SODIUM solution, concentrate 100 mg/5mL (ANDA)
|
Rising Pharma Holdings, Inc. |
CROMOLYN SODIUM |
D00526
|
|
Milrinone Lactate injection, solution 1 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Milrinone Lactate |
D02085
|
|
Nystatin suspension 100000 [USP'U]/mL (ANDA)
|
Pharmaceutical Associates, Inc. |
NYSTATIN |
D00202
|
|
palonosetron hydrochloride injection .25 mg/5mL (NDA AUTHORIZED GENERIC)
|
Cipla USA Inc. |
palonosetron hydrochloride |
D05343
|
Rizatriptan Benzoate tablet 5 mg (ANDA)
Rizatriptan Benzoate tablet 10 mg (ANDA)
|
Cipla USA Inc. |
Rizatriptan Benzoate |
D00675
|
|
Ranitidine syrup 15 mg/mL (ANDA)
|
Pharmaceutical Associates, Inc. |
RANITIDINE |
D00673
|
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 10 mg (ANDA)
Quinapril and Hydrochlorothiazide 20/12.5 tablet 20 mg (ANDA)
Quinapril and Hydrochlorothiazide 20/25 tablet 20 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
|
|
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
|
|
Magnesium Sulfate injection, solution 500 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
MAGNESIUM SULFATE HEPTAHYDRATE |
D01108
|
Methylphenidate Hydrochloride solution 5 mg/5mL (ANDA)
Methylphenidate Hydrochloride solution 10 mg/5mL (ANDA)
|
Ascend Laboratories, LLC |
Methylphenidate Hydrochloride |
D01296
|
|
Lessina kit (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Levonorgestrel and Ethinyl Estradiol |
D04482
|
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
|
|
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
|
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
|
|
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
|
|
Naloxone Hydrochloride injection 1 mg/mL (ANDA)
|
International Medication Systems, Limited |
Naloxone Hydrochloride |
D01340
|
|
LIDOCAINE HCl and EPINEPHRINE injection 15 mg/mL (ANDA)
|
B. Braun Medical Inc. |
LIDOCAINE HCl and EPINEPHRINE |
D04052
|