| Product |
Company |
Generic name |
KEGG DRUG |
Buprenorphine patch, extended release 5 ug/h (ANDA)
Buprenorphine patch, extended release 10 ug/h (ANDA)
Buprenorphine patch, extended release 15 ug/h (ANDA)
Buprenorphine patch, extended release 20 ug/h (ANDA)
Buprenorphine patch, extended release 7.5 ug/h (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Buprenorphine |
D07132
|
|
SPIRONOLACTONE tablet, film coated 100 mg (ANDA)
|
Bryant Ranch Prepack |
SPIRONOLACTONE |
D00443
|
Azithromycin powder, for suspension 100 mg/5mL (ANDA)
Azithromycin powder, for suspension 200 mg/5mL (ANDA)
|
AiPing Pharmaceutical, Inc. |
Azithromycin |
D02134
|
Ampicillin and Sulbactam injection, powder, for solution 1 g (ANDA)
Ampicillin and Sulbactam injection, powder, for solution 2 g (ANDA)
|
Hospira, Inc |
Ampicillin sodium and Sulbactam sodium |
D02065
|
|
ACETAMINOPHEN AND CODEINE PHOSPHATE tablet 300 mg (ANDA)
|
A-S Medication Solutions |
acetaminophen and codeine phosphate |
D02146
|
|
Zycubo injection, powder, lyophilized, for solution 2.9 mg (NDA)
|
Sentynl Therapeutics, Inc. |
copper histidinate |
D13117
|
|
arformoterol tartrate solution 15 ug/2mL (ANDA)
|
Lifestar Pharma LLC |
arformoterol tartrate |
D02981
|
|
tizanidine hydrochloride capsule 4 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
tizanidine hydrochloride |
D00776
|
|
hydrocortisone valerate cream cream 2 mg/g (ANDA)
|
Bryant Ranch Prepack |
hydrocortisone valerate cream |
D02288
|
|
TYRUKO injection 300 mg5mL (BLA)
|
Sandoz Inc |
natalizumab-sztn |
D06886
|
CHANTIX tablet, film coated .5 mg (NDA)
CHANTIX tablet, film coated 1 mg (NDA)
CHANTIX kit (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
varenicline tartrate |
D06282
|
|
Candesartan Cilexetil and Hydrochlorothiazide tablet 16 mg (ANDA)
|
Mylan Pharmaceuticals Inc. |
candesartan cilexetil and hydrochlorothiazide |
D09196
|
|
FLUOCINOLONE ACETONIDE Oil oil .11 mg/mL (ANDA)
|
RISING PHARMA HOLDINGS, INC. |
fluocinolone acetonide |
D01825
|
|
Zolpidem Tartrate tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions |
Zolpidem Tartrate |
D00706
|
Simponi injection, solution 50 mg/.5mL (BLA)
Simponi injection, solution 100 mg/mL (BLA)
|
Janssen Biotech, Inc. |
golimumab |
D04358
|
Bumetanide tablet .5 mg (ANDA)
Bumetanide tablet 1 mg (ANDA)
Bumetanide tablet 2 mg (ANDA)
|
NCS HealthCare of KY, LLC dba Vangard Labs |
Bumetanide |
D00247
|
Sertraline Hydrochloride capsule 150 mg (ANDA)
Sertraline Hydrochloride capsule 200 mg (ANDA)
|
Dr. Reddy's Laboratories Inc. |
Sertraline Hydrochloride |
D00825
|
|
Bupropion hydrochloride tablet, extended release 150 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Bupropion hydrochloride |
D00817
|
|
Amoxicillin and Clavulanate Potassium suspension 600 mg/5mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
leuprolide acetate kit (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
leuprolide acetate |
D00989
|
Metoprolol succinate tablet, film coated, extended release 25 mg (ANDA)
Metoprolol succinate tablet, film coated, extended release 50 mg (ANDA)
|
Dr. Reddy's Laboratories Inc |
Metoprolol succinate |
D00635
|
|
Omeprazole capsule, delayed release 40 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Omeprazole |
D00455
|
|
Amitriptyline Hydrochloride tablet 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Amitriptyline Hydrochloride |
D00809
|
Metoprolol succinate tablet, film coated, extended release 100 mg (ANDA)
Metoprolol succinate tablet, film coated, extended release 200 mg (ANDA)
|
Dr. Reddy's Laboratories Inc |
Metoprolol succinate |
D00635
|
|
levofloxacin tablet, film coated 500 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
levofloxacin |
D00588
|
|
Etodolac capsule 300 mg (ANDA)
|
Northwind Health Company, LLC |
Etodolac |
D00315
|
|
Gemfibrozil tablet 600 mg (ANDA)
|
Northwind Health Company, LLC |
Gemfibrozil |
D00334
|
|
Sertraline Hydrochloride tablet, film coated 100 mg (ANDA)
|
Northwind Health Company, LLC |
Sertraline Hydrochloride |
D00825
|
|
Glipizide tablet 5 mg (ANDA)
|
Northwind Health Company, LLC |
Glipizide |
D00335
|
|
Escitalopram tablet, film coated 10 mg (ANDA)
|
Northwind Health Company, LLC |
Escitalopram |
D02567
|
|
BiDil tablet, film coated 37.5 mg (NDA)
|
Azurity Pharmaceuticals, Inc. |
Hydralazine hydrochloride and Isosorbide dinitrate |
D10209
|
Juxtapid capsule 10 mg (NDA)
Juxtapid capsule 20 mg (NDA)
|
Amryt Pharmaceuticals DAC |
lomitapide mesylate |
D09638
|
|
Meclizine Hydrochloride tablet 25 mg (ANDA)
|
Northwind Health Company, LLC |
Meclizine Hydrochloride |
D01317
|
|
Promethazine Hydrochloride tablet 25 mg (ANDA)
|
Northwind Health Company, LLC |
Promethazine Hydrochloride |
D00480
|
|
Escitalopram tablet, film coated 20 mg (ANDA)
|
Northwind Health Company, LLC |
Escitalopram Oxalate |
D02567
|
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE solution, concentrate 17.5 g/mL (NDA)
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE solution, concentrate 13.13 g33.1mL (NDA)
|
Affordable Pharmaceuticals, LLC |
sodium sulfate, potassium sulfate, magnesium sulfate |
D11985
|
|
YARTEMLEA injection 370 mg/2mL (BLA)
|
Omeros Corporation |
narsoplimab |
D11531
|
|
Sildenafil tablet 20 mg (ANDA)
|
Northwind Health Company, LLC |
Sildenafil |
D02229
|
|
Esomeprazole Magnesium capsule, delayed release 20 mg (ANDA)
|
A-S Medication Solutions |
Esomeprazole Magnesium |
D01984
|
|
Ursodiol capsule 300 mg (NDA AUTHORIZED GENERIC)
|
AvKARE |
Ursodiol |
D00734
|