| Product |
Company |
Generic name |
KEGG DRUG |
|
Oxygen gas 990 mL/L (NDA)
|
DJB Gas Services, Inc |
Oxygen |
D00003
|
|
Dilantin Infatabs tablet, chewable 50 mg (ANDA)
|
Parke-Davis Div of Pfizer Inc |
Phenytoin |
D00512
|
Zolpidem Tartrate tablet, extended release 6.25 mg (ANDA)
Zolpidem Tartrate tablet, extended release 12.5 mg (ANDA)
|
Breckenridge Pharmaceutical, Inc. |
Zolpidem Tartrate |
D00706
|
|
Hydromorphone Hydrochloride solution 1 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
hydromorphone hydrochloride |
D00839
|
VFEND powder, for suspension 40 mg/mL (NDA)
VFEND tablet, film coated 50 mg (NDA)
VFEND tablet, film coated 200 mg (NDA)
VFEND injection, powder, lyophilized, for solution 10 mg/mL (NDA)
|
Roerig |
voriconazole |
D00578
|
Conjugated Estrogens tablet, film coated .3 mg (NDA AUTHORIZED GENERIC)
Conjugated Estrogens tablet, film coated .45 mg (NDA AUTHORIZED GENERIC)
Conjugated Estrogens tablet, film coated .625 mg (NDA AUTHORIZED GENERIC)
Conjugated Estrogens tablet, film coated .9 mg (NDA AUTHORIZED GENERIC)
Conjugated Estrogens tablet, film coated 1.25 mg (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
estrogens, conjugated |
D04070
|
|
Mefenamic Acid capsule 250 mg (ANDA)
|
Misemer Pharmaceuticals, Inc |
Mefenamic Acid |
D00151
|
|
sodium chloride injection, solution 9 mg/mL (NDA)
|
Medefil, Inc. |
SODIUM CHLORIDE |
D02056
|
|
Amoxicillin and Clavulanate Potassium tablet 875 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amoxicillin and Clavulanate Potassium |
D06485
|
|
Zoledronic acid injection 5 mg00mL (ANDA)
|
Gland Pharma Limited |
Zoledronic acid |
D01968
|
Metoprolol Succinate tablet, extended release 25 mg (ANDA)
Metoprolol Succinate tablet, extended release 50 mg (ANDA)
Metoprolol Succinate tablet, extended release 100 mg (ANDA)
Metoprolol Succinate tablet, extended release 200 mg (ANDA)
|
BluePoint Laboratories |
Metoprolol Succinate |
D00635
|
|
Ebanga injection, powder, lyophilized, for solution 400 mg/8mL (BLA)
|
Emergent Manufacturing Operations Baltimore, LLC |
Ansuvimab |
D11875
|
|
PHENYTOIN SODIUM capsule 100 mg (ANDA)
|
DIRECT RX |
PHENYTOIN SODIUM |
D02103
|
|
Carvedilol tablet, film coated 25 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Carvedilol |
D00255
|
Hydromorphone Hydrochloride tablet 2 mg (ANDA)
Hydromorphone Hydrochloride tablet 4 mg (ANDA)
|
American Health Packaging |
Hydromorphone Hydrochloride |
D00839
|
|
Air gas 210 mL/L (NDA)
|
DJB Gas Services, Inc |
Air |
D03043
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
Unichem Pharmaceuticals (USA), Inc. |
Labetalol Hydrochloride |
D00600
|
|
Ondansetron tablet, orally disintegrating 4 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Ondansetron |
D00456
|
|
Indomethacin capsule, extended release 75 mg (ANDA)
|
Northwind Health Company, LLC |
Indomethacin |
D00141
|
|
Dexmedetomidine Hydrochloride injection 4 ug/mL (ANDA)
|
Gland Pharma Limited |
Dexmedetomidine Hydrochloride |
D01205
|
|
metoprolol succinate tablet, film coated, extended release 50 mg (ANDA)
|
Northwind Health Company, LLC |
metoprolol succinate |
D00635
|
|
Bupropion Hydrochloride SR tablet, film coated, extended release 150 mg (ANDA)
|
Epic Pharma, LLC |
bupropion hydrochloride |
D00817
|
Elrexfio injection, solution 44 mg.1mL (BLA)
Elrexfio injection, solution 76 mg.9mL (BLA)
|
Pfizer Laboratories Div Pfizer Inc |
elranatamab-bcmm |
D12058
|
Bupropion Hydrochloride XL tablet, extended release 150 mg (ANDA)
Bupropion Hydrochloride XL tablet, extended release 300 mg (ANDA)
|
Epic Pharma, LLC |
bupropion hydrochloride |
D00817
|
|
SUSTOL injection 10 mg/.4mL (NDA)
|
Heron Therapeutics, Inc. |
granisetron |
D04370
|
Baclofen tablet 5 mg (ANDA)
Baclofen tablet 10 mg (ANDA)
Baclofen tablet 20 mg (ANDA)
|
Lifestar Pharma LLC |
Baclofen |
D00241
|
|
tadalafil tablet, film coated 20 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
tadalafil |
D02008
|
|
SIMVASTATIN tablet, film coated 40 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
SIMVASTATIN |
D00434
|
Shingrix kit (BLA)
Shingrix injection, solution 50 ug/.5mL (BLA)
|
GlaxoSmithKline Biologicals SA |
Zoster Vaccine Recombinant, Adjuvanted |
D11562
|
|
Terconazole cream 4 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
terconazole |
D00888
|
|
SIMVASTATIN tablet, film coated 20 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
SIMVASTATIN |
D00434
|
Tacrolimus ointment 1 mg/g (ANDA)
Tacrolimus ointment .3 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
tacrolimus |
D00107
|
|
FENOPRON TM capsule 300 mg (ANDA)
|
Galt Pharmaceuticals, LLC |
FENOPROFEN CALCIUM |
D00968
|
|
Fenofibrate capsule 130 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Fenofibrate |
D00565
|
|
Hydrocortisone ointment 10 mg/g (ANDA)
|
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC |
Hydrocortisone |
D00088
|
|
Metronidazole cream 7.5 mg/g (ANDA)
|
Fougera Pharmaceuticals, LLC |
Metronidazole |
D00409
|
|
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Amitriptyline Hydrochloride |
D00809
|
|
Methadone Hydrochloride tablet 10 mg (ANDA)
|
VistaPharm, LLC |
Methadone |
D02102
|
|
Mercaptopurine tablet 50 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Mercaptopurine |
D00161
|
|
Misoprostol tablet 200 ug (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Misoprostol |
D00419
|