| Product |
Company |
Generic name |
KEGG DRUG |
OGIVRI injection, powder, lyophilized, for solution 150 mg/7.4mL (BLA)
OGIVRI injection, powder, lyophilized, for solution 420 mg/20mL (BLA)
OGIVRI kit (BLA)
|
Biocon Biologics Inc. |
trastuzumab-dkst |
D03257
|
|
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
|
REMEDYREPACK INC. |
Amitriptyline Hydrochloride |
D00809
|
Vancomycin Hydrochloride injection, powder, for solution 750 mg (NDA)
Vancomycin Hydrochloride injection, powder, for solution 1.25 g (NDA)
Vancomycin Hydrochloride injection, powder, for solution 1.5 g (NDA)
|
Avenacy, LLC |
vancomycin hydrochloride |
D00926
|
|
Amoxicillin and Clavulanate Potassium tablet, film coated 875 mg (ANDA)
|
REMEDYREPACK INC. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Ferumoxytol injection 510 mg7mL (ANDA)
|
Sandoz Inc |
ferumoxytol |
D04177
|
Hydralazine Hydrochloride tablet 25 mg (ANDA)
Hydralazine Hydrochloride tablet 100 mg (ANDA)
|
Bryant Ranch Prepack |
Hydralazine Hydrochloride |
D01302
|
Ramipril capsule 1.25 mg (ANDA)
Ramipril capsule 2.5 mg (ANDA)
Ramipril capsule 5 mg (ANDA)
Ramipril capsule 10 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Ramipril |
D00421
|
|
POMBILITI ATGA injection, powder, lyophilized, for solution 105 mg (BLA)
|
AMICUS THERAPEUTICS US, LLC |
cipaglucosidase alfa-atga |
D11798
|
|
IQIRVO tablet, film coated 80 mg (NDA)
|
Ipsen Biopharmaceuticals, Inc. |
elafibranor |
D11208
|
|
METFORMIN HYDROCHLORIDE tablet, film coated 500 mg (ANDA)
|
Proficient Rx LP |
METFORMIN HYDROCHLORIDE |
D00944
|
|
Fingolimod capsule .5 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Fingolimod |
D04187
|
|
Rosuvastatin Calcium tablet, film coated 40 mg (ANDA)
|
REMEDYREPACK INC. |
Rosuvastatin Calcium |
D01915
|
Hydralazine Hydrochloride tablet 25 mg (ANDA)
Hydralazine Hydrochloride tablet 50 mg (ANDA)
|
Cardinal Health 107, LLC |
Hydralazine Hydrochloride |
D01302
|
|
hydrALAZINE Hydrochloride injection 20 mg/mL (ANDA)
|
REMEDYREPACK INC. |
hydrALAZINE Hydrochloride |
D01302
|
|
Ebanga injection, powder, lyophilized, for solution 400 mg/8mL (BLA)
|
Emergent BioDefense Operations Lansing LLC |
Ansuvimab |
D11875
|
|
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Cardinal Health 107, LLC |
Cyclobenzaprine Hydrochloride |
D00772
|
Digoxin tablet 250 ug (ANDA)
Digoxin tablet 125 ug (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
DIGOXIN |
D00298
|
|
Ethambutol Hydrochloride tablet 100 mg (ANDA)
|
REMEDYREPACK INC. |
Ethambutol Hydrochloride |
D00878
|
|
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
|
Cardinal Health 107, LLC |
pantoprazole sodium |
D02593
|
|
Celecoxib capsule 200 mg (ANDA)
|
REMEDYREPACK INC. |
Celecoxib |
D00567
|
|
Glipizide tablet, extended release 2.5 mg (ANDA)
|
REMEDYREPACK INC. |
Glipizide |
D00335
|
Deferasirox tablet, for suspension 125 mg (ANDA)
Deferasirox tablet, for suspension 250 mg (ANDA)
Deferasirox tablet, for suspension 500 mg (ANDA)
|
Teva Pharmaceuticals, Inc. |
Deferasirox |
D03669
|
|
Lacosamide injection 10 mg/mL (ANDA)
|
Fosun Pharma USA |
Lacosamide |
D07299
|
|
Pregabalin capsule 150 mg (ANDA)
|
REMEDYREPACK INC. |
Pregabalin |
D02716
|
|
Metoprolol Succinate tablet, film coated, extended release 25 mg (ANDA)
|
Proficient Rx LP |
Metoprolol Succinate |
D00635
|
|
Trazodone Hydrochloride tablet 50 mg (ANDA)
|
American Health Packaging |
Trazodone Hydrochloride |
D00820
|
Neulasta injection 6 mg/.6mL (BLA)
Neulasta kit (BLA)
Neulasta solution 4 mg/.4mL (BLA)
|
Amgen, Inc |
pegfilgrastim |
D06889
|
|
Rocuronium injection, solution 10 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
ROCURONIUM BROMIDE |
D00765
|
|
ofloxacin solution 3 mg/mL (ANDA)
|
Lifestar Pharma LLC |
ofloxacin otic |
D00453
|
FELODIPINE tablet, extended release 2.5 mg (ANDA)
FELODIPINE tablet, extended release 5 mg (ANDA)
FELODIPINE tablet, extended release 10 mg (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
FELODIPINE |
D00319
|
Xylocaine injection, solution 20 ug/mL (ANDA)
Xylocaine injection, solution 10 ug/mL (ANDA)
|
Dentsply Pharmaceutical |
Lidocaine Hydrochloride and Epinephrine Bitartrate |
D04813
|
|
levocetirizine dihydrochloride tablet 5 mg (ANDA)
|
Golden State Medical Supply, Inc. |
levocetirizine dihydrochloride |
D08118
|
Caldolor injection 800 mg/200mL (NDA)
Caldolor injection 800 mg/8mL (NDA)
|
Cumberland Pharmaceuticals Inc. |
ibuprofen |
D00126
|
METFORMIN HYDROCHLORIDE tablet, film coated 500 mg (ANDA)
METFORMIN HYDROCHLORIDE tablet, film coated 1000 mg (ANDA)
|
Quallent Pharmaceuticals Health LLC |
METFORMIN HYDROCHLORIDE |
D00944
|
Dofetilide capsule .5 mg (ANDA)
Dofetilide capsule .25 mg (ANDA)
Dofetilide capsule .125 mg (ANDA)
|
Dr. Reddy's Labratories Inc. |
Dofetilide |
D00647
|
METADATE CD capsule, extended release 10 mg (NDA)
METADATE CD capsule, extended release 20 mg (NDA)
METADATE CD capsule, extended release 30 mg (NDA)
METADATE CD capsule, extended release 40 mg (NDA)
METADATE CD capsule, extended release 50 mg (NDA)
METADATE CD capsule, extended release 60 mg (NDA)
|
Lannett Company, LLC |
methylphenidate hydrochloride |
D01296
|
|
Dorzolamide Hydrochloride and Timolol Maleate solution/ drops 20 mg/mL (ANDA)
|
Aurobindo Pharma Limited |
Dorzolamide Hydrochloride and Timolol Maleate |
D08493
|
|
AURLUMYN injection, solution 100 ug/mL (NDA)
|
BTG International Inc |
ILOPROST |
D02721
|
|
ELEVIDYS kit (BLA)
|
Sarepta Therapeutics, Inc. |
delandistrogene moxeparvovec-rokl |
D12633
|
|
Desmopressin Acetate injection, solution 4 ug/mL (ANDA)
|
The J. Molner Company LLC |
Desmopressin Acetate |
D02235
|