| Product |
Company |
Generic name |
KEGG DRUG |
|
Dilantin Infatabs tablet, chewable 50 mg (ANDA)
|
Parke-Davis Div of Pfizer Inc |
Phenytoin |
D00512
|
|
ZIAGEN solution 20 mg/mL (NDA)
|
ViiV Healthcare Company |
abacavir sulfate |
D00891
|
Ondansetron tablet, orally disintegrating 4 mg (ANDA)
Ondansetron tablet, orally disintegrating 8 mg (ANDA)
|
Aurobindo Pharma Limited |
Ondansetron |
D00456
|
|
TRIAMCINOLONE ACETONIDE cream .25 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
TRIAMCINOLONE ACETONIDE |
D00983
|
|
Diclofenac Sodium solution 16.05 mg/mL (ANDA)
|
REMEDYREPACK INC. |
Diclofenac Sodium |
D00904
|
|
CEFIXIME capsule 400 mg (ANDA)
|
REMEDYREPACK INC. |
CEFIXIME |
D07640
|
|
RELENZA powder 5 mg (NDA)
|
GlaxoSmithKline LLC |
zanamivir |
D00902
|
Deferasirox tablet, for suspension 125 mg (ANDA)
Deferasirox tablet, for suspension 250 mg (ANDA)
Deferasirox tablet, for suspension 500 mg (ANDA)
|
Ascend Laboratories, LLC |
Deferasirox |
D03669
|
DEXTROAMPHETAMINE SULFATE tablet 5 mg (ANDA)
DEXTROAMPHETAMINE SULFATE tablet 10 mg (ANDA)
|
SpecGx LLC |
dextroamphetamine sulfate |
D02078
|
|
BUPROPION HYDROCHLORIDE tablet, extended release 300 mg (ANDA)
|
REMEDYREPACK INC. |
BUPROPION HYDROCHLORIDE |
D00817
|
|
Amoxicillin and Clavulanate Potassium tablet, multilayer, extended release 562.5 mg (ANDA)
|
Sandoz Inc |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Cabergoline tablet .5 mg (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
cabergoline |
D00987
|
SAVAYSA tablet, film coated 15 mg (NDA)
SAVAYSA tablet, film coated 30 mg (NDA)
SAVAYSA tablet, film coated 60 mg (NDA)
|
Daiichi Sankyo Inc. |
EDOXABAN TOSYLATE |
D09546
|
PYZCHIVA injection, solution 45 mg/.5mL (BLA)
PYZCHIVA injection, solution 90 mg/mL (BLA)
PYZCHIVA injection, solution 130 mg/26mL (BLA)
|
SANDOZ INC |
ustekinumab-ttwe |
D09214
|
|
Fulvestrant injection, solution 250 mg/5mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Fulvestrant |
D01161
|
|
Hydrocodone Bitartrate and Acetaminophen solution 325 mg5mL (ANDA)
|
American Health Packaging |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
NALTREXONE HYDROCHLORIDE tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
NALTREXONE HYDROCHLORIDE |
D02095
|
|
Diclofenac Sodium solution 20 mg/g (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
Diclofenac Sodium |
D00904
|
|
Trazodone Hydrochloride tablet, film coated 50 mg (ANDA)
|
REMEDYREPACK INC. |
Trazodone Hydrochloride |
D00820
|
|
Lovastatin tablet 10 mg (ANDA)
|
REMEDYREPACK INC. |
lovastatin |
D00359
|
Divalproex Sodium tablet, delayed release 250 mg (ANDA)
Divalproex Sodium tablet, delayed release 500 mg (ANDA)
|
Major Pharmaceuticals |
Divalproex Sodium |
D00304
|
|
Penicillin V Potassium tablet, film coated 500 mg (ANDA)
|
REMEDYREPACK INC. |
Penicillin V Potassium |
D00497
|
prednisone tablet 10 mg (ANDA)
prednisone tablet 20 mg (ANDA)
prednisone tablet 50 mg (ANDA)
|
Asclemed USA, Inc. |
PREDNISONE |
D00473
|
|
Nyamyc powder 100000 [USP'U]/g (ANDA)
|
Upsher-Smith Laboratories, LLC |
Nystatin |
D00202
|
|
Butalbital, Acetaminophen, and Caffeine tablet 325 mg (ANDA)
|
Major Pharmaceuticals |
Butalbital, Acetaminophen, and Caffeine |
D11850
|
|
Sildenafil powder, for suspension 10 mg/mL (ANDA)
|
Actavis Pharma, Inc. |
Sildenafil |
D02229
|
|
Fluocinolone Acetonide Oil oil .11 mg/mL (ANDA)
|
A-S Medication Solutions |
Fluocinolone Acetonide |
D01825
|
|
Cephalexin capsule 250 mg (ANDA)
|
Bryant Ranch Prepack |
Cephalexin |
D00906
|
|
Torsemide tablet 20 mg (ANDA)
|
Bryant Ranch Prepack |
Torsemide |
D00382
|
|
Irbesartan tablet 150 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Irbesartan |
D00523
|
|
Oxybutynin Chloride tablet 5 mg (ANDA)
|
REMEDYREPACK INC. |
Oxybutynin Chloride |
D00722
|
Sotalol Hydrochloride tablet 80 mg (ANDA)
Sotalol Hydrochloride tablet 160 mg (ANDA)
Sotalol Hydrochloride tablet 240 mg (ANDA)
Sotalol Hydrochloride tablet 120 mg (ANDA)
|
Apotex Corp. |
Sotalol Hydrochloride |
D01026
|
|
Indomethacin capsule 50 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Indomethacin |
D00141
|
|
Selenious Acid injection, solution 60 ug/mL (ANDA)
|
Gland Pharma Limited |
Selenious Acid |
D05814
|
|
Nifedipine tablet, extended release 30 mg (ANDA)
|
REMEDYREPACK INC. |
nifedipine |
D00437
|
RAYOS tablet, delayed release 1 mg (NDA)
RAYOS tablet, delayed release 2 mg (NDA)
RAYOS tablet, delayed release 5 mg (NDA)
|
Horizon Therapeutics USA, Inc. |
prednisone |
D00473
|
|
Tygacil injection, powder, lyophilized, for solution 50 mg/5mL (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
TIGECYCLINE |
D01079
|
|
LIDOCAINE HYDROCHLORIDE solution 40 mg/mL (ANDA)
|
Xttrium Laboratories, Inc. |
Lidocaine Hydrochloride |
D08127
|
Rocuronium Bromide injection 50 mg/5mL (ANDA)
Rocuronium Bromide injection 100 mg0mL (ANDA)
|
Baxter Healthcare Corporation |
Rocuronium Bromide |
D00765
|
|
Benzonatate capsule 100 mg (ANDA)
|
Major Pharmaceuticals |
Benzonatate |
D00242
|