| Product |
Company |
Generic name |
KEGG DRUG |
PRIALT injection, solution 100 ug/mL (NDA)
PRIALT injection, solution 25 ug/mL (NDA)
|
TerSera Therapeutics LLC |
ziconotide acetate |
D08686
|
|
CLINDAMYCIN AND BENZOYL PEROXIDE kit (ANDA)
|
REMEDYREPACK INC. |
clindamycin and benzoyl peroxide |
D10602
|
|
Carisoprodol tablet 350 mg (ANDA)
|
REMEDYREPACK INC. |
Carisoprodol |
D00768
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Golden State Medical Supply, Inc. |
Lidocaine |
D00358
|
Triamterene and Hydrochlorothiazide tablet 25 mg (ANDA)
Triamterene and Hydrochlorothiazide tablet 50 mg (ANDA)
|
Apotex Corp. |
Triamterene and Hydrochlorothiazide |
D10269
|
|
Enpresse kit (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Levonorgestrel and Ethinyl Estradiol |
D04482
|
Donepezil Hydrochloride tablet, film coated 5 mg (ANDA)
Donepezil Hydrochloride tablet, film coated 10 mg (ANDA)
|
Major Pharmaceuticals |
Donepezil Hydrochloride |
D00670
|
|
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
|
|
Amoxicillin and Clavulanate Potassium tablet, multilayer, extended release 562.5 mg (ANDA)
|
Sandoz Inc |
Amoxicillin and Clavulanate Potassium |
D06485
|
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
|
|
Fulvestrant injection, solution 250 mg/5mL (ANDA)
|
Amneal Pharmaceuticals LLC |
Fulvestrant |
D01161
|
|
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
|
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
|
|
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
|
|
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
|
|
Indomethacin capsule 25 mg (ANDA)
|
Preferred Pharmaceuticals, Inc. |
Indomethacin |
D00141
|
|
Baclofen tablet 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Baclofen |
D00241
|