| Product |
Company |
Generic name |
KEGG DRUG |
|
Clobetasol Propionate ointment .5 mg/g (ANDA)
|
Bryant Ranch Prepack |
Clobetasol Propionate Ointment USP, 0.05% |
D01272
|
|
Vivotif capsule, coated 6000000000 [CFU] (BLA)
|
Bavarian Nordic A/S |
Salmonella typhi Ty21a |
D06261
|
|
hydrocortisone lotion 25 mg/mL (ANDA)
|
Bryant Ranch Prepack |
hydrocortisone |
D00088
|
INVEGA SUSTENNA injection 39 mg/.25mL (NDA)
INVEGA SUSTENNA injection 78 mg/.5mL (NDA)
INVEGA SUSTENNA injection 117 mg/.75mL (NDA)
INVEGA SUSTENNA injection 156 mg/mL (NDA)
INVEGA SUSTENNA injection 234 mg.5mL (NDA)
|
Janssen Pharmaceuticals, Inc. |
paliperidone palmitate |
D05340
|
Caldolor injection 800 mg/200mL (NDA)
Caldolor injection 800 mg/8mL (NDA)
|
Cumberland Pharmaceuticals Inc. |
ibuprofen |
D00126
|
|
topiramate tablet, film coated 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
topiramate |
D00537
|
|
Ciclopirox Olamine suspension 7.7 mg00mL (ANDA)
|
Bryant Ranch Prepack |
Ciclopirox Olamine |
D01364
|
|
Vaxchora kit (BLA)
|
Bavarian Nordic A/S |
Cholera Vaccine, Live, Oral |
D03530
|
|
Meclizine Hydrochloride tablet 25 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Meclizine Hydrochloride |
D01317
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Lidocaine |
D00358
|
|
DURYSTA implant 10 ug (NDA)
|
Allergan, Inc. |
bimatoprost |
D02724
|
Hydrochlorothiazide tablet 25 mg (ANDA)
Hydrochlorothiazide tablet 50 mg (ANDA)
|
Proficient Rx LP |
Hydrochlorothiazide |
D00340
|
|
Zidovudine syrup 10 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
Zidovudine |
D00413
|
|
CHLORPROMAZINE HYDROCHLORIDE injection 25 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
CHLORPROMAZINE HYDROCHLORIDE |
D00789
|
|
DEXAMETHASONE SODIUM PHOSPHATE injection, solution 10 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
DEXAMETHASONE SODIUM PHOSPHATE |
D00975
|
AMLODIPINE BESYLATE 2.5 mg tablet 2.5 mg (ANDA)
AMLODIPINE BESYLATE 5 mg tablet 5 mg (ANDA)
AMLODIPINE BESYLATE 10 mg tablet 10 mg (ANDA)
|
Proficient Rx LP |
AMLODIPINE BESYLATE |
D00615
|
|
Labetalol Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Caplin Steriles Limited |
Labetalol Hydrochloride |
D00600
|
Carvedilol tablet, film coated 6.25 mg (ANDA)
Carvedilol tablet, film coated 25 mg (ANDA)
|
Preferred Pharmaceuticals,Inc. |
Carvedilol |
D00255
|
|
RabAvert kit (BLA)
|
Bavarian Nordic A/S |
Rabies Vaccine |
D06504
|
|
CARVEDILOL tablet, film coated 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
CARVEDILOL |
D00255
|
|
Paroxetine tablet, film coated 10 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
paroxetine hydrochloride hemihydrate |
D02260
|
|
Zidovudine capsule 100 mg (ANDA)
|
Aurobindo Pharma Limited |
Zidovudine |
D00413
|
Spironolactone tablet, coated 25 mg (ANDA)
Spironolactone tablet, coated 50 mg (ANDA)
Spironolactone tablet, coated 100 mg (ANDA)
|
Proficient Rx LP |
Spironolactone |
D00443
|
|
Osphena tablet, film coated 60 mg (NDA)
|
Duchesnay USA, Inc. |
Ospemifene |
D08958
|
|
Sirolimus solution 1 mg/mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
SIrolimus |
D00753
|
INVEGA TRINZA injection, suspension, extended release 273 mg/.88mL (NDA)
INVEGA TRINZA injection, suspension, extended release 410 mg.32mL (NDA)
INVEGA TRINZA injection, suspension, extended release 546 mg.75mL (NDA)
INVEGA TRINZA injection, suspension, extended release 819 mg/2.63mL (NDA)
|
Janssen Pharmaceuticals, Inc |
paliperidone palmitate |
D05340
|
|
Milrinone Lactate injection, solution 1 mg/mL (ANDA)
|
Caplin Steriles Limited |
Milrinone Lactate |
D02085
|
|
PANTOPRAZOLE SODIUM injection, powder, lyophilized, for solution 40 mg0mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
PANTOPRAZOLE SODIUM |
D02593
|
|
Quetiapine fumarate tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
quetiapine fumarate |
D00458
|
|
Haloperidol tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Haloperidol |
D00136
|
|
Clobetasol Propionate cream .25 mg/g (NDA AUTHORIZED GENERIC)
|
INA Pharmaceutics Inc |
clobetasol propionate |
D01272
|
|
HYDRALAZINE HYDROCHLORIDE tablet 50 mg (ANDA)
|
Coupler LLC |
hydralazine hydrochloride |
D01302
|
|
PRAVASTATIN SODIUM tablet 10 mg (ANDA)
|
Coupler LLC |
PRAVASTATIN SODIUM |
D00893
|
|
PRAVASTATIN SODIUM tablet 20 mg (ANDA)
|
Coupler LLC |
PRAVASTATIN SODIUM |
D00893
|
|
Isoniazid tablet 300 mg (ANDA)
|
Chartwell RX, LLC |
Isoniazid |
D00346
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
Ajanta Pharma USA Inc. |
ketorolac tromethamine |
D00813
|
|
Lacosamide injection 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Lacosamide |
D07299
|
ESTRADIOL tablet .5 mg (ANDA)
ESTRADIOL tablet 1 mg (ANDA)
ESTRADIOL tablet 2 mg (ANDA)
|
Asclemed USA, Inc. |
ESTRADIOL |
D00105
|
Paroxetine tablet, film coated 10 mg (ANDA)
Paroxetine tablet, film coated 20 mg (ANDA)
Paroxetine tablet, film coated 30 mg (ANDA)
Paroxetine tablet, film coated 40 mg (ANDA)
|
Asclemed USA, Inc. |
Paroxetine |
D02260
|
|
Omeprazole capsule, delayed release 10 mg (ANDA)
|
Chartwell RX, LLC |
Omeprazole |
D00455
|