| Product |
Company |
Generic name |
KEGG DRUG |
ACAM2000 injection, powder, lyophilized, for solution 100000000 [PFU]/mL (BLA)
Diluent for ACAM2000 solution (BLA)
|
Emergent Product Development Gaithersburg Inc. |
smallpox and mpox (vaccinia) vaccine, live |
|
|
Lacosamide solution 10 mg/mL (ANDA)
|
American Health Packaging |
Lacosamide |
D07299
|
|
METRONIDAZOLE solution 500 mg00mL (NDA)
|
B. Braun Medical Inc. |
METRONIDAZOLE |
D00409
|
|
Bupropion Hydrochloride tablet, film coated, extended release 150 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
BUPROPION HYDROCHLORIDE |
D00817
|
|
Abiraterone Acetate tablet 250 mg (ANDA)
|
Dr. Reddys Laboratories Inc |
Abiraterone Acetate |
D09701
|
Synjardy tablet 5 mg (NDA)
Synjardy tablet 12.5 mg (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
empagliflozin and metformin hydrochloride |
D10752
|
|
Mometasone Furoate ointment 1 mg (ANDA)
|
Torrent Pharmaceuticals Limited |
Mometasone Furoate |
D00690
|
|
Verapamil Hydrochloride capsule, extended release 100 mg (NDA AUTHORIZED GENERIC)
|
Chartwell RX, LLC |
Verapamil Hydrochloride |
D00619
|
Nicardipine Hydrochloride injection 25 mg0mL (NDA)
Nicardipine Hydrochloride injection .2 mg/mL (NDA)
Nicardipine Hydrochloride injection .1 mg/mL (NDA)
|
Hikma Pharmaceuticals USA Inc. |
Nicardipine Hydrochloride |
D00617
|
RIFAMPIN capsule 150 mg (ANDA)
RIFAMPIN capsule 300 mg (ANDA)
|
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS |
rifampin |
D00211
|
|
Famciclovir tablet, film coated 500 mg (ANDA)
|
Bryant Ranch Prepack |
Famciclovir |
D00317
|
|
Colchicine capsule .6 mg (NDA)
|
Coupler LLC |
Colchicine |
D00570
|
|
Ergocalciferol capsule 1.25 mg (ANDA)
|
Bryant Ranch Prepack |
Ergocalciferol Capsules, |
D00187
|
|
Phentermine Hydrochloride tablet 30 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Phentermine Hydrochloride |
D05459
|
|
Chorionic Gonadotropin kit (BLA)
|
NuCare Pharmaceuticals,Inc. |
Chorionic Gonadotropin |
D03478
|
|
GABAPENTIN tablet 600 mg (ANDA)
|
Coupler LLC |
Gabapentin |
D00332
|
|
Gabapentin tablet 800 mg (ANDA)
|
Coupler LLC |
Gabapentin |
D00332
|
|
Ciprofloxacin tablet 500 mg (ANDA)
|
Coupler LLC |
Ciprofolxacin |
D02216
|
|
Fenofibrate capsule 67 mg (ANDA)
|
Coupler LLC |
Fenofibrate |
D00565
|
|
Paliperidone tablet, extended release 3 mg (ANDA)
|
Coupler LLC |
Paliperidone |
D05339
|
|
Trazodone Hydrochloride tablet 100 mg (ANDA)
|
Coupler LLC |
Trazodone Hydrochloride |
D00820
|
|
Tramadol Hydrochloride tablet, coated 100 mg (ANDA)
|
Coupler LLC |
Tramadol Hydrochloride |
D01355
|
|
Thiothixene capsule 10 mg (ANDA)
|
Coupler LLC |
Thiothixene |
D00374
|
Mycophenolate Mofetil tablet, film coated 500 mg (ANDA)
Mycophenolate Mofetil capsule 250 mg (ANDA)
|
Mylan Institutional Inc. |
mycophenolate mofetil |
D00752
|
|
ADAPALENE gel 3 mg/g (ANDA)
|
Alembic Pharmaceuticals Limited |
ADAPALENE |
D01112
|
|
Mupirocin ointment 20 mg/g (ANDA)
|
Lohxa |
Mupirocin |
D01076
|
|
Mono-Linyah kit (ANDA)
|
Northstar Rx LLC |
norgestimate and ethinyl estradiol |
D10590
|
|
Hydralazine Hydrochloride tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
Hydralazine Hydrochloride |
D01302
|
|
Ondansetron injection 2 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Ondansetron |
D00678
|
|
Nystatin suspension 100000 U/mL (NDA AUTHORIZED GENERIC)
|
Chartwell RX, LLC |
Nystatin |
D00202
|
Amlodipine and Olmesartan Medoxomil tablet, film coated 5 mg (ANDA)
Amlodipine and Olmesartan Medoxomil tablet, film coated 10 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Amlodipine and Olmesartan Medoxomil |
D10285
|
|
VOWST capsule 30000000 [CFU] (BLA)
|
Aimmune Therapeutics, Inc. |
fecal microbiota spores, live-brpk |
|
|
Digoxin injection .25 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Digoxin |
D00298
|
|
Tretinoin capsule 10 mg (ANDA)
|
Endo USA, Inc. |
Tretinoin |
D00094
|
neffy spray 2 mg00uL (NDA)
neffy spray 1 mg00uL (NDA)
|
ARS Pharmaceuticals Operations, Inc. |
epinephrine |
D00095
|
|
CLOBETASOL PROPIONATE cream .5 mg/g (ANDA)
|
Alembic Pharmaceuticals Limited |
CLOBETASOL PROPIONATE |
D01272
|
Aripiprazole tablet 2 mg (ANDA)
Aripiprazole tablet 5 mg (ANDA)
Aripiprazole tablet 10 mg (ANDA)
Aripiprazole tablet 15 mg (ANDA)
Aripiprazole tablet 20 mg (ANDA)
Aripiprazole tablet 30 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Aripiprazole |
D01164
|
Micardis HCT tablet 12.5 mg (NDA)
Micardis HCT tablet 25 mg (NDA)
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
telmisartan and hydrochlorothiazide |
D09219
|
|
Atovaquone suspension 750 mg/5mL (ANDA)
|
Lohxa |
Atovaquone |
D00236
|
TASCENSO ODT tablet, orally disintegrating .25 mg (NDA)
TASCENSO ODT tablet, orally disintegrating .5 mg (NDA)
|
Cycle Pharmaceuticals Ltd |
Fingolimod Lauryl Sulfate |
D12549
|