| Product |
Company |
Generic name |
KEGG DRUG |
|
COSELA injection, powder, lyophilized, for solution 300 mg/20mL (NDA)
|
Pharmacosmos Therapeutics Inc.
|
trilaciclib
|
D11987
|
|
BRINZOLAMIDE suspension/ drops 10 mg/mL (ANDA)
|
Padagis US LLC
|
brinzolamide
|
D00652
|
|
Azurette kit (ANDA)
|
Mayne Pharma Inc.
|
desogestrel/ethinyl estradiol and ethinyl estradiol
|
D04484
|
|
Tilia Fe kit (ANDA)
|
Mayne Pharma Inc.
|
NdAc and EE Tablets and Ferrous Fumarate Tablets
|
D04483
|
|
Permethrin cream 50 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Permethrin Cream 5% w/w
|
D05443
|
|
Risperidone kit (ANDA)
|
Amneal Pharmaceuticals LLC
|
risperidone
|
D00426
|
Irbesartan tablet 75 mg (ANDA)
Irbesartan tablet 150 mg (ANDA)
Irbesartan tablet 300 mg (ANDA)
|
Macleods Pharmaceuticals Limited
|
Irbesartan
|
D00523
|
Yutrepia capsule 26.5 ug (NDA)
Yutrepia capsule 53 ug (NDA)
Yutrepia capsule 79.5 ug (NDA)
Yutrepia capsule 106 ug (NDA)
|
Liquidia Technologies, Inc.
|
treprostinil
|
D08628
|
|
ampicillin sodium and sulbactam sodium injection, powder, for solution 2 g (ANDA)
|
Civica, Inc.
|
ampicillin sodium and sulbactam sodium
|
D02065
|
|
Daptomycin injection, powder, lyophilized, for solution 500 mg (NDA)
|
MAIA Pharmaceuticals, Inc.
|
Daptomycin
|
D01080
|
|
Gadobutrol injection 604.72 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
Gadobutrol
|
D07420
|
Lurasidone Hydrochloride tablet, film coated 20 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 40 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 60 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 80 mg (ANDA)
Lurasidone Hydrochloride tablet, film coated 120 mg (ANDA)
|
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Inc.
|
Lurasidone Hydrochloride
|
D04820
|
|
Mometasone Furoate cream 1 mg/g (ANDA)
|
Bryant Ranch Prepack
|
Mometasone Furoate
|
D00690
|
|
PANTOPRAZOLE SODIUM tablet, delayed release 40 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
PANTOPRAZOLE
|
D02593
|
Paroxetine tablet, film coated 10 mg (ANDA)
Paroxetine tablet, film coated 20 mg (ANDA)
|
Preferred Pharmaceuticals, Inc
|
Paroxetine Hydrochloride
|
D02260
|
|
Phentermine Hydrochloride capsule 15 mg (ANDA)
|
Bryant Ranch Prepack
|
phentermine hydrochloride
|
D05459
|
|
Amoxicillin powder, for suspension 125 mg/5mL (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Amoxicillin
|
D00229
|
Pemetrexed injection, powder, lyophilized, for solution 100 mg/4mL (ANDA)
Pemetrexed injection, powder, lyophilized, for solution 500 mg/20mL (ANDA)
Pemetrexed injection, powder, lyophilized, for solution 750 mg/30mL (ANDA)
Pemetrexed injection, powder, lyophilized, for solution 1 g/40mL (ANDA)
|
Fresenius Kabi USA, LLC
|
PEMETREXED DISODIUM
|
D03828
|
|
Pantoprazole tablet, delayed release 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Pantoprazole
|
D02593
|
|
OXCARBAZEPINE tablet, film coated 600 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
OXCARBAZEPINE
|
D00533
|
|
Paroxetine tablet, film coated 30 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Paroxetine
|
D02260
|
|
Phentermine Hydrochloride capsule 30 mg (ANDA)
|
Bryant Ranch Prepack
|
phentermine hydrochloride
|
D05459
|
|
Sevelamer Carbonate tablet, film coated 800 mg (ANDA)
|
DR. REDDY'S LABORATORIES LIMITED
|
Sevelamer Carbonate
|
D06642
|
|
Bupropion hydrochloride tablet, extended release 150 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Bupropion hydrochloride
|
D00817
|
|
Lithium carbonate tablet, film coated, extended release 300 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
|
Lithium carbonate
|
D00801
|
|
Nefazodone Hydrochloride tablet 150 mg (ANDA)
|
Bryant Ranch Prepack
|
Nefazodone Hydrochloride
|
D00819
|
Enalapril Maleate tablet 2.5 mg (ANDA)
Enalapril Maleate tablet 5 mg (ANDA)
Enalapril Maleate tablet 10 mg (ANDA)
Enalapril Maleate tablet 20 mg (ANDA)
|
Solco Healthcare US, LLC
|
Enalapril Maleate
|
D00621
|
|
NALOXONE HYDROCHLORIDE injection, solution .4 mg/mL (ANDA)
|
Henry Schein, Inc.
|
naloxone hydrochloride
|
D01340
|
|
Esomeprazole magnesium capsule, delayed release 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Esomeprazole magnesium
|
D01984
|
|
Lansoprazole capsule, delayed release 30 mg (ANDA)
|
A-S Medication Solutions
|
Lansoprazole
|
D00355
|
|
Oseltamivir phosphate for suspension 6 mg/mL (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Oseltamivir phosphate
|
D00900
|
|
LEVOTHYROXINE SODIUM tablet 100 ug (ANDA)
|
A-S Medication Solutions
|
LEVOTHYROXINE SODIUM
|
D01010
|
|
NUVAXOVID COVID-19 Vaccine, Adjuvanted injection, suspension 5 ug/.5mL (BLA)
|
Novavax, Inc.
|
nvx-cov2705
|
D12336
|
|
Clobetasol Propionate ointment .5 mg/g (ANDA)
|
Encube Ethicals, Inc.
|
Clobetasol Propionate Ointment USP, 0.05%
|
D01272
|
|
Dapsone gel 75 mg/g (ANDA)
|
Trupharma, LLC
|
Dapsone
|
D00592
|
|
Metoprolol Succinate tablet, film coated, extended release 25 mg (ANDA)
|
Preferred Pharmaceuticals Inc.
|
Metoprolol Succinate
|
D00635
|
|
LEVOTHYROXINE SODIUM tablet 100 ug (ANDA)
|
A-S Medication Solutions
|
LEVOTHYROXINE SODIUM
|
D01010
|
Dasatinib tablet, film coated 20 mg (ANDA)
Dasatinib tablet, film coated 50 mg (ANDA)
Dasatinib tablet, film coated 70 mg (ANDA)
Dasatinib tablet, film coated 100 mg (ANDA)
Dasatinib tablet, film coated 80 mg (ANDA)
Dasatinib tablet, film coated 140 mg (ANDA)
|
Apotex Corp.
|
Dasatinib
|
D06414
|
|
Terazosin capsule 10 mg (ANDA)
|
Bryant Ranch Prepack
|
Terazosin Hydrochloride
|
D11585
|
|
Sterile Water injection, solution 1 mL/mL (ANDA)
|
Henry Schein, Inc.
|
water injection
|
D00001
|