| Product |
Company |
Generic name |
KEGG DRUG |
NUPLAZID capsule 34 mg (NDA)
NUPLAZID tablet, coated 10 mg (NDA)
|
Acadia Pharmaceuticals Inc. |
pimavanserin tartrate |
D08969
|
Caldolor injection 800 mg/200mL (NDA)
Caldolor injection 800 mg/8mL (NDA)
|
Cumberland Pharmaceuticals Inc. |
ibuprofen |
D00126
|
|
Divalproex Sodium tablet, delayed release 125 mg (ANDA)
|
American Health Packaging |
Divalproex Sodium |
D00304
|
|
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
|
|
ONDANSETRON injection 2 mg/mL (ANDA)
|
Apotex Corp. |
ONDANSETRON |
D00678
|
|
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
|
|
Atorvastatin calcium tablet, film coated 40 mg (ANDA)
|
ST. MARY'S MEDICAL PARK PHARMACY |
Atorvastatin calcium |
D02258
|
|
Mycophenolate Mofetil injection, powder, lyophilized, for solution 500 mg/20mL (ANDA)
|
BPI Labs LLC |
Mycophenolate Mofetil hydrochloride |
D05094
|
|
Testosterone Gel, 1% gel 10 mg/g (ANDA)
|
Bryant Ranch Prepack |
Testosterone Gel, 1% |
D00075
|
|
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
|
|
Carvedilol tablet, film coated 12.5 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Carvedilol |
D00255
|
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
|
|
ESTRADIOL AND NORETHINDRONE ACETATE tablet 1 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
estradiol and norethindrone acetate |
D09188
|
|
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
|
Lisdexamfetamine Dimesylate capsule 20 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 30 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 40 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 50 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 60 mg (ANDA)
Lisdexamfetamine Dimesylate capsule 70 mg (ANDA)
|
Amneal Pharmaceuticals LLC |
Lisdexamfetamine |
D04747
|
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
|
|
Fluorouracil injection, solution 50 mg/mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Fluorouracil |
D00584
|
escitalopram tablet, film coated 10 mg (ANDA)
escitalopram tablet, film coated 20 mg (ANDA)
|
Major Pharmaceuticals |
escitalopram |
D02567
|
|
Quetiapine fumarate tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
quetiapine fumarate |
D00458
|
|
Haloperidol tablet 1 mg (ANDA)
|
Bryant Ranch Prepack |
Haloperidol |
D00136
|
POTASSIUM CITRATE tablet, extended release 540 mg (ANDA)
POTASSIUM CITRATE tablet, extended release 1080 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
potassium citrate |
D05578
|
|
Clobetasol Propionate cream .25 mg/g (NDA AUTHORIZED GENERIC)
|
INA Pharmaceutics Inc |
clobetasol propionate |
D01272
|
PREVYMIS tablet, film coated 240 mg (NDA)
PREVYMIS tablet, film coated 480 mg (NDA)
PREVYMIS injection, solution 20 mg/mL (NDA)
PREVYMIS pellet 120 mg (NDA)
PREVYMIS pellet 20 mg (NDA)
|
Merck Sharp & Dohme LLC |
LETERMOVIR |
D10801
|