| Product |
Company |
Generic name |
KEGG DRUG |
|
Sodium Phenylacetate and Sodium Benzoate injection, solution, concentrate 100 mg/mL (ANDA)
|
FOSUN PHARMA USA INC
|
Sodium Phenylacetate and Sodium Benzoate
|
D10205
|
|
Finasteride tablet, film coated 5 mg (ANDA)
|
A-S Medication Solutions
|
Finasteride
|
D00321
|
|
Amcinonide cream 1 mg/g (ANDA)
|
INA PHARMACEUTICS INC.
|
Amcinonide
|
D01387
|
|
Levonorgestrel and Ethinyl Estradiol kit (ANDA)
|
Naari Pte Limited
|
Levonorgestrel and Ethinyl Estradiol
|
D04482
|
|
OXYCODONE AND ACETAMINOPHEN tablet 325 mg (ANDA)
|
Bryant Ranch Prepack
|
Oxycodone and Acetaminophen
|
D02153
|
|
Sincalide injection, powder, lyophilized, for solution 5 ug/5mL (NDA)
|
FOSUN PHARMA USA INC
|
Sincalide
|
D05845
|
|
Omeprazole capsule, delayed release 20 mg (ANDA)
|
QPharma Inc
|
Omeprazole
|
D00455
|
|
prednisone tablet 10 mg (ANDA)
|
QPharma Inc
|
PREDNISONE
|
D00473
|
|
Prednisone tablet 20 mg (ANDA)
|
QPharma Inc
|
Prednisone
|
D00473
|
|
Pantoprazole Sodium tablet, delayed release 40 mg (ANDA)
|
QPharma Inc
|
pantoprazole sodium
|
D02593
|
|
Palonosetron Hydrochloride injection, solution .05 mg/mL (ANDA)
|
Avenacy, Inc.
|
palonosetron hydrochloride
|
D05343
|
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
|
QPharma Inc
|
Carvedilol
|
D00255
|
CINACALCET tablet 30 mg (ANDA)
CINACALCET tablet 60 mg (ANDA)
CINACALCET tablet 90 mg (ANDA)
|
Cipla USA Inc.
|
CINACALCET
|
D03505
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 1.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 2.5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 3.75 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 5 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 6.25 mg (ANDA)
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate capsule, extended release 7.5 mg (ANDA)
|
Elite Laboratories, Inc.
|
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
|
D11624
|
Bupropion Hydrochloride SR tablet, film coated, extended release 100 mg (ANDA)
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
Bupropion Hydrochloride SR tablet, film coated, extended release 200 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc.
|
bupropion hydrochloride
|
D00817
|
|
Citalopram tablet, film coated 20 mg (ANDA)
|
QPharma Inc
|
Citalopram Hydrobromide
|
D00822
|
|
Clotrimazole lozenge 10 mg (ANDA)
|
Hikma Pharmacuticals USA USA Inc.
|
Clotrimazole
|
D00282
|
|
PHYTONADIONE injection, emulsion 1 mg/.5mL (ANDA)
|
Henry Schein, Inc.
|
phytonadione
|
D00148
|
Bupropion Hydrochloride SR tablet, film coated, extended release 100 mg (ANDA)
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
Bupropion Hydrochloride SR tablet, film coated, extended release 200 mg (ANDA)
|
Radha Pharmaceuticals, Inc.
|
bupropion hydrochloride
|
D00817
|
PREGABALIN capsule 25 mg (ANDA)
PREGABALIN capsule 50 mg (ANDA)
PREGABALIN capsule 75 mg (ANDA)
PREGABALIN capsule 100 mg (ANDA)
PREGABALIN capsule 150 mg (ANDA)
PREGABALIN capsule 200 mg (ANDA)
PREGABALIN capsule 225 mg (ANDA)
PREGABALIN capsule 300 mg (ANDA)
|
Cadila Pharmaceuticals Limited
|
PREGABALIN
|
D02716
|
|
Jasmiel kit (ANDA)
|
Afaxys Pharma, LLC
|
Drospirenone and Ethinyl Estradiol
|
D09741
|
|
Famotidine tablet, film coated 40 mg (ANDA)
|
REMEDYREPACK INC.
|
Famotidine
|
D00318
|
|
CHLORPROMAZINE HCI injection 25 mg/mL (ANDA)
|
Dr. Reddy's Laboratories Inc.,
|
CHLORPROMAZINE HCI
|
D00789
|
|
Isoproterenol Hydrochloride injection, solution .2 mg/mL (ANDA)
|
Avenacy, Inc.
|
isoproterenol hydrochloride
|
D01390
|
Mircera injection, solution 30 ug/.3mL (BLA)
Mircera injection, solution 50 ug/.3mL (BLA)
Mircera injection, solution 75 ug/.3mL (BLA)
Mircera injection, solution 100 ug/.3mL (BLA)
Mircera injection, solution 150 ug/.3mL (BLA)
Mircera injection, solution 200 ug/.3mL (BLA)
Mircera injection, solution 250 ug/.3mL (BLA)
Mircera injection, solution 120 ug/.3mL (BLA)
Mircera injection, solution 360 ug/.6mL (BLA)
|
Vifor (International) Inc.
|
Methoxy polyethylene glycol-epoetin beta
|
D09998
|
|
Amoxicillin capsule 500 mg (ANDA)
|
QPharma Inc
|
Amoxicillin
|
D00229
|
|
Metoprolol Tartrate tablet, film coated 50 mg (ANDA)
|
QPharma Inc
|
Metoprolol Tartrate
|
D00601
|
Cisatracurium Besylate injection 20 mg0mL (ANDA)
Cisatracurium Besylate injection 10 mg/5mL (ANDA)
|
Eugia US LLC
|
Cisatracurium Besylate
|
D00759
|
|
Hydrochlorothiazide capsule 12.5 mg (ANDA)
|
Rising Pharma Holdings, Inc.
|
Hydrochlorothiazide
|
D00340
|
Glyburide and Metformin Hydrochloride tablet, film coated 1.25 mg (ANDA)
Glyburide and Metformin Hydrochloride tablet, film coated 2.5 mg (ANDA)
Glyburide and Metformin Hydrochloride tablet, film coated 5 mg (ANDA)
|
Rising Pharma Holdings, Inc.
|
Glyburide and Metformin Hydrochloride
|
D10266
|
Alprazolam tablet .25 mg (ANDA)
Alprazolam tablet .5 mg (ANDA)
|
ATLANTIC BIOLOGICALS CORP.
|
Alprazolam
|
D00225
|
Torsemide tablet 5 mg (ANDA)
Torsemide tablet 10 mg (ANDA)
Torsemide tablet 20 mg (ANDA)
Torsemide tablet 100 mg (ANDA)
|
Rising Pharma Holdings, Inc.
|
Torsemide
|
D00382
|
|
Fluoxetine capsule 10 mg (ANDA)
|
Bryant Ranch Prepack
|
Fluoxetine Hydrochloride
|
D00823
|
|
Methenamine Hippurate tablet 1 g (ANDA)
|
Jubilant Cadista Pharmaceuticals Inc.
|
Methenamine Hippurate
|
D00855
|
|
Metoprolol succinate tablet, extended release 100 mg (ANDA)
|
Major Pharmaceuticals
|
Metoprolol succinate
|
D00635
|
|
hydrochlorothiazide capsule 12.5 mg (ANDA)
|
QPharma Inc
|
hydrochlorothiazide
|
D00340
|
|
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
Bryant Ranch Prepack
|
Labetalol Hydrochloride
|
D00600
|
ArmonAir Digihaler powder, metered 55 ug (NDA)
ArmonAir Digihaler powder, metered 113 ug (NDA)
ArmonAir Digihaler powder, metered 232 ug (NDA)
|
Teva Respiratory, LLC
|
Fluticasone Propionate
|
D01708
|
|
Amoxicillin capsule 500 mg (ANDA)
|
QPharma Inc
|
Amoxicillin
|
D00229
|
|
Sertraline Hydrochloride tablet, film coated 50 mg (ANDA)
|
QPharma Inc
|
Sertraline Hydrochloride
|
D00825
|