| Product |
Company |
Generic name |
KEGG DRUG |
|
Amantadine HCl capsule, liquid filled 100 mg (ANDA)
|
AvKARE |
AMANTADINE HYDROCHLORIDE |
D00777
|
|
ENFLONSIA injection, solution 150 mg/mL (BLA)
|
Merck Sharp & Dohme LLC |
CLESROVIMAB |
D12153
|
Prucalopride tablet, film coated 1 mg (ANDA)
Prucalopride tablet, film coated 2 mg (ANDA)
|
Cipla USA Inc. |
Prucalopride |
D10152
|
RETACRIT injection, solution 2000 [iU]/mL (BLA)
RETACRIT injection, solution 3000 [iU]/mL (BLA)
RETACRIT injection, solution 4000 [iU]/mL (BLA)
RETACRIT injection, solution 10000 [iU]/mL (BLA)
RETACRIT injection, solution 20000 [iU]/mL (BLA)
|
Vifor (International) Inc. |
epoetin alfa-epbx |
D03231
|
|
nystatin tablet, coated 500000 [USP'U] (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
nystatin |
D00202
|
KYPROLIS injection, powder, lyophilized, for solution 60 mg/30mL (NDA)
KYPROLIS injection, powder, lyophilized, for solution 30 mg5mL (NDA)
KYPROLIS injection, powder, lyophilized, for solution 10 mg/5mL (NDA)
|
Onyx Pharmaceuticals, Inc. |
carfilzomib |
D08880
|
|
ANKTIVA solution 400 ug/.4mL (BLA)
|
Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. |
nogapendekin alfa inbakicept-pmln |
D12888
|
Mirtazapine tablet, orally disintegrating 15 mg (ANDA)
Mirtazapine tablet, orally disintegrating 30 mg (ANDA)
Mirtazapine tablet, orally disintegrating 45 mg (ANDA)
|
Viona Pharmaceuticals Inc. |
Mirtazapine |
D00563
|
|
ADMELOG injection, solution 100 U/mL (BLA)
|
Sanofi-Aventis U.S. LLC |
insulin lispro |
D04477
|
|
Olanzapine tablet, film coated 5 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
Olanzapine |
D00454
|
|
Phenylephrine Hydrochloride injection 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Phenylephrine Hydrochloride |
D00511
|
Maraviroc tablet, film coated 300 mg (ANDA)
Maraviroc tablet, film coated 150 mg (ANDA)
|
Navinta LLC |
Maraviroc |
D06670
|
|
METOPROLOL TARTRATE tablet 50 mg (ANDA)
|
Bryant Ranch Prepack |
METOPROLOL TARTRATE |
D00601
|
diltiazem hydrochloride capsule, extended release 120 mg (ANDA)
diltiazem hydrochloride capsule, extended release 180 mg (ANDA)
diltiazem hydrochloride capsule, extended release 240 mg (ANDA)
diltiazem hydrochloride capsule, extended release 300 mg (ANDA)
diltiazem hydrochloride capsule, extended release 360 mg (ANDA)
|
Ingenus Pharmaceuticals, LLC |
diltiazem hydrochloride |
D00616
|
|
Dehydrated Alcohol injection, solution 1 mL/mL (ANDA)
|
XGen Pharmaceuticals DJB, Inc. |
Alcohol |
D00068
|
|
Allopurinol tablet 100 mg (ANDA)
|
NuCare Pharmaceuticals,Inc. |
Allopurinol |
D00224
|
Erythromycin Ethylsuccinate granule, for suspension 200 mg/5mL (ANDA)
Erythromycin Ethylsuccinate granule, for suspension 400 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Erythromycin Ethylsuccinate |
D01361
|
|
Erythromycin Ethylsuccinate granule, for suspension 200 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Erythromycin Ethylsuccinate |
D01361
|
Clindamycin Hydrochloride capsule 150 mg (ANDA)
Clindamycin Hydrochloride capsule 300 mg (ANDA)
|
American Health Packaging |
Clindamycin Hydrochloride |
D02132
|
GABAPENTIN capsule 100 mg (ANDA)
GABAPENTIN capsule 400 mg (ANDA)
GABAPENTIN capsule 300 mg (ANDA)
|
Exelan Pharmaceuticals, Inc. |
GABAPENTIN |
D00332
|
|
FLUOXETINE solution 20 mg/5mL (ANDA)
|
Saptalis Pharmaceuticals, LLC. |
FLUOXETINE |
D00823
|
SINGULAIR granule 4 mg (NDA)
SINGULAIR tablet, chewable 4 mg (NDA)
SINGULAIR tablet, film coated 10 mg (NDA)
SINGULAIR tablet, chewable 5 mg (NDA)
|
Organon LLC |
montelukast sodium |
D00529
|
|
Metoclopramide solution 5 mg/5mL (ANDA)
|
ANI Pharmaceuticals, Inc. |
Metoclopramide |
D05008
|
Azithromycin tablet, film coated 250 mg (ANDA)
Azithromycin tablet, film coated 500 mg (ANDA)
|
American Health Packaging |
Azithromycin |
D02134
|
Gabapentin tablet, film coated 600 mg (ANDA)
Gabapentin tablet, film coated 800 mg (ANDA)
|
American Health Packaging |
Gabapentin |
D00332
|
GABAPENTIN capsule 100 mg (ANDA)
GABAPENTIN capsule 400 mg (ANDA)
GABAPENTIN capsule 300 mg (ANDA)
|
Cipla USA Inc. |
GABAPENTIN |
D00332
|
|
Amikacin Sulfate injection, solution 250 mg/mL (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Amikacin Sulfate |
D00865
|
Leflunomide tablet 10 mg (ANDA)
Leflunomide tablet 20 mg (ANDA)
|
KVK-Tech, Inc. |
Leflunomide |
D00749
|
Meclizine Hydrochloride tablet 25 mg (ANDA)
Meclizine Hydrochloride tablet 12.5 mg (ANDA)
|
American Health Packaging |
Meclizine Hydrochloride |
D01317
|
|
Ketorolac Tromethamine tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
ketorolac tromethamine |
D00813
|
|
Potassium Chloride tablet, extended release 20 meq (ANDA)
|
American Health Packaging |
Potassium Chloride |
D02060
|
|
Flecainide Acetate tablet 150 mg (ANDA)
|
Bryant Ranch Prepack |
flecainide acetate |
D00638
|
|
Sertraline tablet, film coated 25 mg (ANDA)
|
Bryant Ranch Prepack |
Sertraline |
D00825
|
Dexrazoxane injection, powder, lyophilized, for solution 500 mg/50mL (ANDA)
Dexrazoxane injection, powder, lyophilized, for solution 250 mg/25mL (ANDA)
|
Gland Pharma Limited |
Dexrazoxane for Injection |
D07807
|
Dabigatran Etexilate capsule, coated pellets 75 mg (ANDA)
Dabigatran Etexilate capsule, coated pellets 110 mg (ANDA)
Dabigatran Etexilate capsule, coated pellets 150 mg (ANDA)
|
Major Pharmaceuticals |
Dabigatran Etexilate |
D07082
|
|
Budesonide capsule, delayed release 3 mg (ANDA)
|
Amneal Pharmaceuticals of New York LLC |
Budesonide |
D00246
|
|
Ketoconazole tablet 200 mg (ANDA)
|
Amici Pharma Inc. |
Ketoconazole |
D00351
|
Warfarin Sodium tablet 1 mg (ANDA)
Warfarin Sodium tablet 2 mg (ANDA)
Warfarin Sodium tablet 2.5 mg (ANDA)
Warfarin Sodium tablet 3 mg (ANDA)
Warfarin Sodium tablet 4 mg (ANDA)
Warfarin Sodium tablet 6 mg (ANDA)
Warfarin Sodium tablet 10 mg (ANDA)
Warfarin Sodium tablet 5 mg (ANDA)
Warfarin Sodium tablet 7.5 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Warfarin Sodium |
D00564
|
|
Amoxicillin capsule 250 mg (ANDA)
|
Bryant Ranch Prepack |
Amoxicillin |
D00229
|
|
Ketorolac Tromethamine injection, solution 15 mg/mL (ANDA)
|
Henry Schein, Inc. |
Ketorolac tromethamine |
D00813
|