| Product |
Company |
Generic name |
KEGG DRUG |
Tretinoin Cream cream .5 mg/g (NDA)
Tretinoin Cream cream .25 mg/g (NDA)
Tretinoin Cream cream 1 mg/g (NDA)
|
Obagi Cosmeceuticals LLC |
tretinoin |
D00094
|
|
Buprenorphine Hydrochloride injection .324 mg/mL (ANDA)
|
Somerset Therapeutics, LLC |
Buprenorphine Hydrochloride |
D00836
|
Rosuvastatin tablet, film coated 5 mg (ANDA)
Rosuvastatin tablet, film coated 10 mg (ANDA)
Rosuvastatin tablet, film coated 20 mg (ANDA)
Rosuvastatin tablet, film coated 40 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Rosuvastatin |
D01915
|
|
epinephrine injection 1 mg/mL (ANDA)
|
Gland Pharma Limited |
epinephrine |
D00095
|
LOKELMA powder, for suspension 5 g/5g (NDA)
LOKELMA powder, for suspension 10 g0g (NDA)
|
AstraZeneca Pharmaceuticals LP |
sodium zirconium cyclosilicate |
D10727
|
IFOSFAMIDE injection, powder, for solution 1 g/20mL (NDA)
IFOSFAMIDE injection, powder, for solution 3 g/60mL (NDA)
|
Baxter Healthcare Corporation |
IFOSFAMIDE |
D00343
|
|
Nitrogen gas 990 mL/L (NDA)
|
Big Branch Breeders Service |
Nitrogen |
D00083
|
PRASUGREL tablet, film coated 5 mg (ANDA)
PRASUGREL tablet, film coated 10 mg (ANDA)
|
Panacea Biotec Limited |
PRASUGREL |
D05597
|
|
CLOBETASOL PROPIONATE spray .05 g/mL (ANDA)
|
Alembic Pharmaceuticals Limited |
CLOBETASOL PROPIONATE |
D01272
|
|
AMPHETAMINE SULFATE tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
amphetamine sulfate |
D02074
|
|
OXCARBAZEPINE suspension 60 mg/mL (ANDA)
|
Camber Pharmaceuticals, Inc. |
OXCARBAZEPINE |
D00533
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
cyclobenzaprine hydrochloride |
D00772
|
|
Prednisolone Sodium Phosphate solution 20 mg/5mL (ANDA)
|
PAI Holdings, LLC dba PAI Pharma |
Prednisolone Sodium Phosphate |
D00981
|
|
Levofloxacin solution/ drops 15 mg/mL (ANDA)
|
BPI LABS LLC |
Levofloxacin |
D00588
|
IFEX injection, powder, for solution 1 g/20mL (NDA)
IFEX injection, powder, for solution 3 g/60mL (NDA)
|
Baxter Healthcare Corporation |
ifosfamide |
D00343
|
|
CARMUSTINE kit (NDA AUTHORIZED GENERIC)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
CARMUSTINE |
D00254
|
|
TOBI Podhaler capsule 28 mg (NDA)
|
Viatris Specialty LLC |
Tobramycin |
D00063
|
|
Midazolam Hydrochloride injection, solution 5 mg/mL (ANDA)
|
Belcher Pharmaceuticals, LLC |
Midazolam Hydrochloride |
D00696
|
|
Aminocaproic acid solution .25 g/mL (ANDA)
|
BPI LABS LLC |
Aminocaproic acid |
D00160
|
|
PRAVASTATIN SODIUM tablet 20 mg (ANDA)
|
Bryant Ranch Prepack |
PRAVASTATIN SODIUM |
D00893
|
|
Bupropion Hydrochloride SR tablet, film coated, extended release 100 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
bupropion hydrochloride |
D00817
|
|
Omega-3-Acid Ethyl Esters capsule 1 g (ANDA)
|
KD Pharma USA, Inc. |
Omega-3-Acid Ethyl Esters |
D05255
|
|
Budesonide Inhalation Suspension inhalant .5 mg/2mL (ANDA)
|
Preferred Pharmaceuticals Inc. |
Budesonide |
D00246
|
|
budesonide inhalation suspension .5 mg/2mL (ANDA)
|
Preferred Pharmaceuticals, Inc. |
budesonide inhalation |
D00246
|
|
Bupropion Hydrochloride tablet, film coated 100 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Bupropion Hydrochloride |
D00817
|
IFOSFAMIDE injection, powder, for solution 1 g/20mL (NDA)
IFOSFAMIDE injection, powder, for solution 3 g/60mL (NDA)
|
Baxter Healthcare Corporation |
ifosfamide |
D00343
|
|
Esmolol Hydrochloride injection 10 mg/mL (NDA)
|
Baxter Healthcare Corporation |
Esmolol Hydrochloride |
D00644
|
|
Perforomist solution 20 ug/2mL (NDA)
|
Viatris Specialty LLC |
formoterol fumarate dihydrate |
D05277
|
Crenessity capsule 25 mg (NDA)
Crenessity capsule 50 mg (NDA)
Crenessity capsule 100 mg (NDA)
Crenessity solution 50 mg/mL (NDA)
|
Neurocrine Biosciences, Inc. |
crinecerfont |
D12366
|
Tikosyn capsule .125 mg (NDA)
Tikosyn capsule .25 mg (NDA)
Tikosyn capsule .5 mg (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
dofetilide |
D00647
|
|
Estradiol Valerate and Estradiol Valerate/Dienogest kit (NDA AUTHORIZED GENERIC)
|
Sandoz Inc |
estradiol valerate and estradiol valerate/dienogest |
D10461
|
|
NITROGEN gas 99 L00L (NDA)
|
Crumpton Welding Supply & Equipment, Inc. |
NITROGEN |
D00083
|
|
Linezolid powder, for suspension 100 mg/5mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
linezolid |
D00947
|
METFORMIN HYDROCHLORIDE EXTENDED RELEASE tablet, extended release 500 mg (ANDA)
METFORMIN HYDROCHLORIDE EXTENDED RELEASE tablet, extended release 750 mg (ANDA)
|
TIME CAP LABORATORIES, INC |
Metformin Hydrochloride |
D00944
|
|
Fulvicin P/G 165 tablet 165 mg (ANDA)
|
Solubiomix, LLC. |
ULTRAMICROSIZE GRISEOFULVIN |
D00209
|
|
ERVEBO injection, solution 72000000 [PFU]/mL (BLA)
|
Merck Sharp & Dohme LLC |
ZAIRE EBOLAVIRUS (STRAIN KIKWIT-95) ENVELOPE GLYCOPROTEIN |
|
|
Folic Acid tablet 1 mg (ANDA)
|
Coupler LLC |
Folic Acid |
D00070
|
|
Prednisone tablet 2.5 mg (ANDA)
|
Coupler LLC |
Prednisone |
D00473
|
|
Promethazine Hydrochloride tablet 50 mg (ANDA)
|
Coupler LLC |
Promethazine Hydrochloride |
D00480
|
|
ISOSORBIDE MONONITRATE tablet, extended release 30 mg (ANDA)
|
Coupler LLC |
ISOSORBIDE MONONITRATE |
D00630
|