| Product |
Company |
Generic name |
KEGG DRUG |
|
Gabapentin tablet, film coated 800 mg (ANDA)
|
Bryant Ranch Prepack |
GABAPENTIN |
D00332
|
|
Gabapentin tablet, film coated 600 mg (ANDA)
|
Bryant Ranch Prepack |
GABAPENTIN |
D00332
|
|
Trifluoperazine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
Trifluoperazine Hydrochloride |
D00799
|
|
Trospium Chloride tablet, film coated 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Trospium Chloride |
D01103
|
Liothyronine sodium tablet 5 ug (ANDA)
Liothyronine sodium tablet 25 ug (ANDA)
Liothyronine sodium tablet 50 ug (ANDA)
|
Biocon Pharma Inc. |
Liothyronine sodium |
D01011
|
|
Ixinity kit (BLA)
|
Medexus Pharma, Inc. |
coagulation factor IX (recombinant) |
D08797
|
|
BIVALIRUDIN injection, powder, lyophilized, for solution 250 mg/5mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
BIVALIRUDIN |
D11280
|
|
Lithium Carbonate tablet, film coated, extended release 300 mg (ANDA)
|
A-S Medication Solutions |
Lithium Carbonate |
D00801
|
Paroxetine tablet, film coated, extended release 12.5 mg (ANDA)
Paroxetine tablet, film coated, extended release 25 mg (ANDA)
Paroxetine tablet, film coated, extended release 37.5 mg (ANDA)
|
Cadila Pharmaceuticals Limited |
Paroxetine |
D02260
|
|
Nitrofurantoin suspension 25 mg/5mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Nitrofurantoin |
D00439
|
|
Quetiapine Fumarate tablet, film coated 100 mg (ANDA)
|
A-S Medication Solutions |
Quetiapine Fumarate |
D00458
|
|
CLINDAMYCIN PHOSPHATE gel 10 mg/g (ANDA)
|
Alembic Pharmaceuticals Inc. |
CLINDAMYCIN PHOSPHATE |
D01073
|
|
Ranolazine tablet, film coated, extended release 500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
RANOLAZINE |
D05700
|
|
Trulance Immediate release tablet 3 mg (NDA)
|
Salix Pharmaceuticals Inc. |
Plecanatide |
D09948
|
VANCOMYCIN HYDROCHLORIDE injection, powder, lyophilized, for solution 500 mg0mL (ANDA)
VANCOMYCIN HYDROCHLORIDE injection, powder, lyophilized, for solution 1 g/20mL (ANDA)
|
Fresenius Kabi USA, LLC |
VANCOMYCIN HYDROCHLORIDE |
D00926
|
Rizatriptan Benzoate tablet 5 mg (ANDA)
Rizatriptan Benzoate tablet 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Rizatriptan Benzoate |
D00675
|
|
Ezetimibe tablet 10 mg (ANDA)
|
Golden State Medical Supply, Inc. |
Ezetimibe |
D01966
|
Potassium Chloride solution 3 g5mL (ANDA)
Potassium Chloride solution 1.5 g5mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Potassium Chloride |
D02060
|
|
Prednisone tablet 5 mg (ANDA)
|
A-S Medication Solutions |
Prednisone |
D00473
|
|
Divalproex Sodium tablet, delayed release 125 mg (ANDA)
|
A-S Medication Solutions |
Divalproex Sodium |
D00304
|
|
Fluocinonide Cream cream .5 mg/g (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Fluocinonide |
D00325
|
|
Pyridostigmine Bromide solution 60 mg/5mL (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Pyridostigmine Bromide |
D00487
|
|
Foscarnet Sodium injection, solution 24 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
foscarnet sodium |
D02267
|
Metoprolol Tartrate tablet, film coated 25 mg (ANDA)
Metoprolol Tartrate tablet, film coated 50 mg (ANDA)
Metoprolol Tartrate tablet, film coated 100 mg (ANDA)
|
Golden State Medical Supply, Inc. |
metoprolol tartrate |
D00601
|
|
Megestrol Acetate suspension 40 mg/mL (ANDA)
|
Precision Dose Inc. |
Megestrol Acetate |
D00952
|
|
Megestrol Acetate suspension 40 mg/mL (ANDA)
|
Precision Dose Inc. |
Megestrol Acetate |
D00952
|
|
VARENICLINE tablet, film coated .5 mg (ANDA)
|
Bryant Ranch Prepack |
VARENICLINE |
D06282
|
Risperidone tablet, film coated .25 mg (ANDA)
Risperidone tablet, film coated .5 mg (ANDA)
Risperidone tablet, film coated 1 mg (ANDA)
Risperidone tablet, film coated 2 mg (ANDA)
Risperidone tablet, film coated 3 mg (ANDA)
Risperidone tablet, film coated 4 mg (ANDA)
|
Chartwell RX, LLC |
Risperidone |
D00426
|
|
Fludarabine phosphate injection, powder, lyophilized, for solution 50 mg/2mL (ANDA)
|
Actavis Pharma, Inc. |
Fludarabine phosphate |
D01907
|
INDOMETHACIN capsule 50 mg (ANDA)
INDOMETHACIN capsule 25 mg (ANDA)
|
DIRECT RX |
INDOMETHACIN |
D00141
|
|
R-Gene injection, solution 10 g00mL (NDA)
|
Pharmacia & Upjohn Company LLC |
Arginine Hydrochloride |
D01126
|
|
Fosfomycin Tromethamine granule, for solution 3 g (ANDA)
|
Amneal Pharmaceuticals NY LLC |
Fosfomycin Tromethamine |
D00925
|
Montelukast Sodium tablet, chewable 4 mg (ANDA)
Montelukast Sodium tablet, chewable 5 mg (ANDA)
Montelukast Sodium tablet, film coated 10 mg (ANDA)
|
Aurobindo Pharma Limited |
Montelukast Sodium |
D00529
|
|
Inveltys suspension 10 mg/mL (NDA)
|
ALCON LABORATORIES, INC. |
loteprednol etabonate |
D01689
|
|
Melphalan Hydrochloride kit (ANDA)
|
Sagent Pharmaceuticals |
Melphalan Hydrochloride |
D08173
|
BACLOFEN tablet 5 mg (ANDA)
BACLOFEN tablet 10 mg (ANDA)
BACLOFEN tablet 20 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
BACLOFEN |
D00241
|
|
Protamine Sulfate injection, solution 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
PROTAMINE SULFATE |
D02224
|
|
Chlorpromazine Hydrochloride injection 25 mg/mL (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Chlorpromazine Hydrochloride |
D00789
|
|
Voriconazole injection, powder, lyophilized, for solution 10 mg/mL (NDA)
|
Xellia Pharmaceuticals USA LLC |
Voriconazole |
D00578
|
Humulin R U-500 injection, solution 500 [iU]/mL (BLA)
Humulin R U-500 KwikPen injection, solution 500 [iU]/mL (BLA)
|
Eli Lilly and Company |
Insulin human |
D03230
|