| Product |
Company |
Generic name |
KEGG DRUG |
Piroxicam capsule 10 mg (ANDA)
Piroxicam capsule 20 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Piroxicam |
D00127
|
|
Fenofibrate tablet, film coated 54 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Fenofibrate |
D00565
|
|
QUADRACEL injection, suspension 20 ug/.5mL (BLA)
|
Sanofi Vaccines US Inc. |
diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine |
D10214
|
Tadalafil tablet, film coated 2.5 mg (ANDA)
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
Tadalafil tablet, film coated 20 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Tadalafil |
D02008
|
|
BESREMi injection 500 ug/mL (BLA)
|
PharmaEssentia USA |
ROPEGINTERFERON ALFA-2B |
D11027
|
Dipyridamole tablet 25 mg (ANDA)
Dipyridamole tablet 50 mg (ANDA)
Dipyridamole tablet 75 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
DIPYRIDAMOLE |
D00302
|
|
Oxygen gas 990 mL/L (NDA)
|
Linde Gas & Equipment Inc. |
Oxygen |
D00003
|
Topiramate capsule, extended release 25 mg (ANDA)
Topiramate capsule, extended release 50 mg (ANDA)
Topiramate capsule, extended release 100 mg (ANDA)
Topiramate capsule, extended release 150 mg (ANDA)
Topiramate capsule, extended release 200 mg (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Topiramate |
D00537
|
|
CHOLESTYRAMINE powder, for suspension 4 g/9g (ANDA)
|
Zydus Lifesciences Limited |
CHOLESTYRAMINE |
D02690
|
|
Colchicine tablet, film coated .6 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Colchicine |
D00570
|
|
CHOLESTYRAMINE powder, for suspension 4 g/9g (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
CHOLESTYRAMINE |
D02690
|
Tetracycline Hydrochloride capsule 250 mg (ANDA)
Tetracycline Hydrochloride capsule 500 mg (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Tetracycline Hydrochloride |
D02122
|
|
IBU tablet 400 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Ibuprofen |
D00126
|
Cyclosporine capsule, gelatin coated 25 mg (ANDA)
Cyclosporine capsule, gelatin coated 100 mg (ANDA)
|
Apotex Corp. |
Cyclosporine |
D00184
|
|
Potassium Acetate injection, solution, concentrate 196.3 mg/mL (NDA)
|
Hospira, Inc. |
POTASSIUM ACETATE |
D01154
|
|
Lidocaine ointment 50 mg/g (ANDA)
|
Macleods Pharmaceuticals Limited |
Lidocaine |
D00358
|
|
Potassium Acetate injection, solution, concentrate 3.93 g/20mL (NDA)
|
Hospira, Inc. |
POTASSIUM ACETATE |
D01154
|
ziprasidone hydrochloride capsule 20 mg (ANDA)
ziprasidone hydrochloride capsule 40 mg (ANDA)
ziprasidone hydrochloride capsule 60 mg (ANDA)
ziprasidone hydrochloride capsule 80 mg (ANDA)
|
Apotex Corp. |
Ziprasidone HCl |
D01939
|
|
Amlodipine Besylate tablet 2.5 mg (ANDA)
|
REMEDYREPACK INC. |
Amlodipine besylate |
D00615
|
|
Gemcitabine injection, solution 38 mg/mL (NDA)
|
Hospira, Inc. |
GEMCITABINE |
D01155
|
|
Duavee tablet, film coated 20 mg (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
conjugated estrogens/bazedoxifene |
D10579
|
|
Potassium Acetate injection, solution, concentrate 196.3 mg/mL (NDA)
|
Hospira, Inc. |
POTASSIUM ACETATE |
D01154
|
|
OMEPRAZOLE capsule, delayed release pellets 40 mg (ANDA)
|
Golden State Medical Supply, Inc. |
OMEPRAZOLE |
D00455
|
Prempro tablet, sugar coated .3 mg (NDA)
Prempro tablet, sugar coated .45 mg (NDA)
Prempro tablet, sugar coated .625 mg (NDA)
Premphase kit (NDA)
|
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
conjugated estrogens and medroxyprogesterone acetate |
|
|
Folic Acid tablet 1 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Folic Acid |
D00070
|
Meclizine Hydrochloride tablet 12.5 mg (ANDA)
Meclizine Hydrochloride tablet 25 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Meclizine Hydrochloride |
D01317
|
|
lithium carbonate capsule 150 mg (ANDA)
|
REMEDYREPACK INC. |
lithium carbonate |
D00801
|
|
acyclovir capsule 200 mg (ANDA)
|
REMEDYREPACK INC. |
acyclovir |
D00222
|
|
Indomethacin capsule 25 mg (ANDA)
|
REMEDYREPACK INC. |
Indomethacin |
D00141
|
Midazolam injection, solution 1 mg/mL (ANDA)
Midazolam injection, solution 5 mg/mL (ANDA)
|
Hospira, Inc. |
MIDAZOLAM HYDROCHLORIDE |
D00696
|
Eltrombopag tablet 12.5 mg (ANDA)
Eltrombopag tablet 25 mg (ANDA)
Eltrombopag tablet 50 mg (ANDA)
Eltrombopag tablet 75 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Eltrombopag Olamine |
D03978
|
|
Cablivi kit (BLA)
|
Genzyme Corporation |
caplacizumab |
D11160
|
ustekinumab injection, solution 45 mg/.5mL (BLA)
ustekinumab injection, solution 90 mg/mL (BLA)
ustekinumab solution 130 mg/26mL (BLA)
|
Janssen Biotech, Inc. |
ustekinumab |
D09214
|
clindamycin hydrochloride capsule 150 mg (NDA AUTHORIZED GENERIC)
clindamycin hydrochloride capsule 300 mg (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
clindamycin hydrochloride |
D02132
|
Alkindi Sprinkle granule .5 mg (NDA)
Alkindi Sprinkle granule 1 mg (NDA)
Alkindi Sprinkle granule 2 mg (NDA)
Alkindi Sprinkle granule 5 mg (NDA)
|
Eton Pharmaceuticals, Inc. |
Hydrocortisone |
D00088
|
|
Bromocriptine mesylate tablet 2.5 mg (ANDA)
|
REMEDYREPACK INC. |
Bromocriptine mesylate |
D00780
|
|
clonidine hydrochloride tablet .2 mg (ANDA)
|
REMEDYREPACK INC. |
Clonidine Hydrochloride |
D00604
|
|
ANDEXXA injection, powder, lyophilized, for solution 200 mg/20mL (BLA)
|
AstraZeneca Pharmaceuticals LP |
andexanet alfa |
D11029
|
Sephience powder 250 mg (NDA)
Sephience powder 1000 mg (NDA)
|
PTC Therapeutics Inc. |
sepiapterin |
D12286
|
|
loteprednol etabonate suspension/ drops 2 mg/mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
loteprednol etabonate |
D01689
|