| Product |
Company |
Generic name |
KEGG DRUG |
|
Ashlyna kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA
|
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
|
D04482
|
|
Hailey Fe 1.5/30 kit (ANDA)
|
Glenmark Pharmaceuticals Inc., USA
|
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
|
D04483
|
|
verapamil hydrochloride injection, solution 2.5 mg/mL (ANDA)
|
Lifestar Pharma LLC
|
verapamil hydrochloride
|
D00619
|
Aripiprazole tablet, orally disintegrating 10 mg (ANDA)
Aripiprazole tablet, orally disintegrating 15 mg (ANDA)
Aripiprazole tablet, orally disintegrating 20 mg (ANDA)
Aripiprazole tablet, orally disintegrating 30 mg (ANDA)
|
SQUARE PHARMACEUTICALS LIMITED
|
Aripiprazole
|
D01164
|
|
Promethazine Hydrochloride tablet 12.5 mg (ANDA)
|
American Health Packaging
|
Promethazine Hydrochloride
|
D00480
|
|
Ganirelix Acetate injection 250 ug/.5mL (ANDA)
|
Amphastar Pharmaceuticals, Inc.
|
Ganirelix Acetate
|
D04302
|
ENALAPRIL MALEATE tablet 20 mg (ANDA)
ENALAPRIL MALEATE tablet 10 mg (ANDA)
ENALAPRIL MALEATE tablet 5 mg (ANDA)
|
A-S Medication Solutions
|
ENALAPRIL MALEATE
|
D00621
|
Zinc Sulfate injection, solution 25 mg/5mL (ANDA)
Zinc Sulfate injection, solution 30 mg0mL (ANDA)
|
Piramal Critical Care Inc.
|
Zinc Sulfate
|
D06371
|
|
Gadoterate Meglumine injection 376.9 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
gadoterate meglumine
|
D03355
|
|
Mesalamine capsule, extended release .375 g (ANDA)
|
American Health Packaging
|
Mesalamine
|
D00377
|
Allopurinol tablet 100 mg (ANDA)
Allopurinol tablet 300 mg (ANDA)
|
American Health Packaging
|
Allopurinol
|
D00224
|
|
Rufinamide tablet, film coated 400 mg (ANDA)
|
American Health Packaging
|
Rufinamide
|
D05775
|
|
Clopidogrel tablet, film coated 75 mg (ANDA)
|
REMEDYREPACK INC.
|
Clopidogrel bisulphate
|
D00769
|
Gabapentin capsule 300 mg (ANDA)
Gabapentin capsule 400 mg (ANDA)
Gabapentin capsule 100 mg (ANDA)
|
A-S Medication Solutions
|
Gabapentin
|
D00332
|
|
venlafaxine hydrochloride capsule, extended release 37.5 mg (ANDA)
|
REMEDYREPACK INC.
|
venlafaxine hydrochloride
|
D00821
|
|
FYARRO injection, powder, lyophilized, for suspension 5 mg/mL (NDA)
|
Aadi Bioscience
|
Sirolimus
|
D00753
|
Mycophenolate Mofetil capsule 250 mg (ANDA)
Mycophenolate Mofetil tablet, film coated 500 mg (ANDA)
|
Golden State Medical Supply, Inc.
|
mycophenolate mofetil
|
D00752
|
ADLYXIN kit (BLA)
ADLYXIN injection, solution 100 ug/mL (BLA)
|
sanofi-aventis U.S. LLC
|
Lixisenatide
|
D09729
|
|
Diclofenac Potassium tablet, film coated 50 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc.
|
Diclofenac Potassium Tablets
|
D00903
|
EPOGEN solution 2000 [iU]/mL (BLA)
EPOGEN solution 3000 [iU]/mL (BLA)
EPOGEN solution 4000 [iU]/mL (BLA)
EPOGEN solution 10000 [iU]/mL (BLA)
EPOGEN solution 20000 [iU]/mL (BLA)
|
Amgen Inc
|
epoetin alfa
|
D03231
|
|
Istalol solution/ drops 5 mg/mL (NDA)
|
Bausch & Lomb Incorporated
|
Timolol Maleate
|
D00603
|
|
MINOCYCLINE HYDROCHLORIDE capsule 100 mg (ANDA)
|
DirectRX
|
MINOCYCLINE HYDROCHLORIDE
|
D00850
|
|
Amoxicillin capsule 500 mg (ANDA)
|
Bryant Ranch Prepack
|
Amoxicillin
|
D00229
|
|
Clomid tablet 50 mg (ANDA)
|
Cosette Pharmaceuticals, Inc.
|
Clomiphene Citrate
|
D00962
|
|
BYDUREON BCise injection, suspension, extended release 2 mg/.85mL (NDA)
|
AstraZeneca Pharmaceuticals LP
|
exenatide
|
D04121
|
Tribenzor tablet, film coated 5 mg (NDA)
Tribenzor tablet, film coated 10 mg (NDA)
|
Cosette Pharmaceuticals, Inc.
|
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
|
D10288
|
|
Hydromorphone Hydrochloride injection, solution 10 mg/mL (ANDA)
|
Hospira, Inc.
|
Hydromorphone Hydrochloride
|
D00839
|
|
Dicloxacillin Sodium capsule 500 mg (ANDA)
|
Bryant Ranch Prepack
|
Dicloxacillin Sodium
|
D02137
|
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)
|
Golden State Medical Supply, Inc.
|
doxepin hydrochloride
|
D00814
|
Trulicity injection, solution .75 mg/.5mL (BLA)
Trulicity injection, solution 1.5 mg/.5mL (BLA)
Trulicity injection, solution 3 mg/.5mL (BLA)
Trulicity injection, solution 4.5 mg/.5mL (BLA)
|
Eli Lilly and Company
|
Dulaglutide
|
D09889
|
|
Lidocaine patch 50 mg/g (ANDA)
|
Northstar RxLLC
|
Lidocaine
|
D00358
|
|
Soliqua 100/33 injection, solution 100 U/mL (BLA)
|
sanofi-aventis U.S. LLC
|
insulin glargine and lixisenatide
|
D11034
|
|
Indium in 111 Oxyquinoline solution 1 ug/mL (NDA)
|
Medi-Physics Inc. dba GE Healthcare.
|
Indium In-111 Oxyquinoline
|
D04526
|
|
Hydrochlorothiazide tablet 25 mg (ANDA)
|
REMEDYREPACK INC.
|
Hydrochlorothiazide
|
D00340
|
|
Famotidine tablet, film coated 20 mg (ANDA)
|
REMEDYREPACK INC.
|
Famotidine
|
D00318
|
|
Byetta injection 250 ug/mL (NDA)
|
AstraZeneca Pharmaceuticals LP
|
exenatide
|
D04121
|
|
TRODELVY powder, for solution 180 mg (BLA)
|
Gilead Sciences
|
SACITUZUMAB GOVITECAN
|
D10985
|
|
Cephalexin capsule 500 mg (ANDA)
|
Bryant Ranch Prepack
|
Cephalexin
|
D00906
|
NOREPINEPHRINE BITARTRATE injection, solution 8 mg/250mL (NDA)
NOREPINEPHRINE BITARTRATE injection, solution 4 mg/250mL (NDA)
|
Baxter Healthcare Corporation
|
norepinephrine bitartrate
|
D05206
|
|
Oxycodone and Acetaminophen tablet 325 mg (ANDA)
|
Quality Care Products, LLC
|
Oxycodone and Acetaminophen
|
D02153
|