| Product |
Company |
Generic name |
KEGG DRUG |
|
Rosuvastatin tablet, film coated 20 mg (ANDA)
|
NuCare Pharmaceuticals, Inc. |
Rosuvastatin |
D01915
|
|
Metronidazole gel 10 mg/g (NDA AUTHORIZED GENERIC)
|
Mayne Pharma Inc. |
metronidazole |
D00409
|
|
Arsenic trioxide injection, solution 2 mg/mL (ANDA)
|
Zydus Pharmaceuticals USA Inc. |
Arsenic trioxide |
D02106
|
|
Quetiapine fumarate tablet, film coated 50 mg (ANDA)
|
Bryant Ranch Prepack |
Quetiapine fumarate |
D00458
|
CELECOXIB capsule 50 mg (ANDA)
CELECOXIB capsule 100 mg (ANDA)
CELECOXIB capsule 200 mg (ANDA)
CELECOXIB capsule 400 mg (ANDA)
|
Micro Labs Limited |
Celecoxib |
D00567
|
|
Glatiramer Acetate injection, solution 40 mg/mL (ANDA)
|
Mylan Pharmaceuticals Inc. |
Glatiramer |
D04318
|
|
PROGESTERONE capsule 200 mg (ANDA)
|
Bryant Ranch Prepack |
PROGESTERONE |
D00066
|
|
Mefenamic acid capsule 250 mg (ANDA)
|
Micro Labs Limited |
Mefenamic acid |
D00151
|
Xylocaine injection, solution .01 mg/mL (NDA)
Xylocaine injection, solution 10 mg/mL (NDA)
Xylocaine injection, solution 20 mg/mL (NDA)
Xylocaine MPF injection, solution 10 mg/mL (NDA)
Xylocaine MPF injection, solution 20 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
D04813
|
|
Yuflyma kit (BLA)
|
CELLTRION USA, Inc. |
adalimumab-aaty |
D02597
|
MISOPROSTOL tablet 100 ug (ANDA)
MISOPROSTOL tablet 200 ug (ANDA)
|
Micro Labs Limited |
Misoprostol |
D00419
|
|
Enspryng injection, solution 120 mg/mL (BLA)
|
Genentech Inc. |
Satralizumab |
D11079
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 750 mg (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.25 g (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.5 g (ANDA)
|
Gland Pharma Limited |
Vancomycin Hydrochloride |
D00926
|
Morphine Sulfate injection 2 mg/mL (ANDA)
Morphine Sulfate injection 4 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Morphine Sulfate |
D00842
|
RELEUKO injection, solution 300 ug/.5mL (BLA)
RELEUKO injection, solution 300 ug/mL (BLA)
RELEUKO injection, solution 480 ug/.8mL (BLA)
RELEUKO injection, solution 480 ug.6mL (BLA)
|
Amneal Pharmaceuticals LLC |
Filgrastim |
D03235
|
|
Fluocinonide ointment .5 mg/g (ANDA)
|
Preferred Pharmaceuticals Inc. |
Fluocinonide |
D00325
|
|
Milrinone Lactate injection, solution 1 mg/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Milrinone Lactate |
D02085
|
PANTOPRAZOLE SODIUM tablet, delayed release 20 mg (ANDA)
PANTOPRAZOLE SODIUM tablet, delayed release 40 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
PANTOPRAZOLE SODIUM |
D02593
|
Octreotide Acetate injection, solution 50 ug/mL (ANDA)
Octreotide Acetate injection, solution 100 ug/mL (ANDA)
Octreotide Acetate injection, solution 500 ug/mL (ANDA)
Octreotide Acetate injection, solution 200 ug/mL (ANDA)
Octreotide Acetate injection, solution 1000 ug/mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Octreotide Acetate |
D06495
|
|
Marcaine Spinal injection, solution 7.5 mg/mL (NDA)
|
Hospira, Inc. |
Bupivacaine Hydrochloride in Dextrose |
D01450
|
|
PRAVASTATIN SODIUM tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
PRAVASTATIN SODIUM |
D00893
|
|
PROCHLORPERAZINE MALEATE tablet, film coated 10 mg (ANDA)
|
Bryant Ranch Prepack |
Prochlorperazine Maleate |
D00479
|
|
Polymyxin B injection, powder, lyophilized, for solution 500000 [USP'U] (ANDA)
|
Eugia US LLC |
Polymyxin B |
D01066
|
|
Daysee kit (ANDA)
|
Lupin Pharmaceuticals, Inc. |
LEVONORGESTREL AND ETHINYL ESTRADIOL |
D04482
|
|
Albuterol Sulfate HFA aerosol, metered 90 ug (NDA AUTHORIZED GENERIC)
|
Prasco Laboratories |
albuterol sulfate |
D00683
|
|
SODIUM CHLORIDE irrigant 900 mg00mL (NDA)
|
Baxter Healthcare Corporation |
sodium chloride |
D02056
|
|
Colesevelam Hydrochloride tablet, film coated 625 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Colesevelam Hydrochloride |
D03582
|
|
Fluconazole tablet 200 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Fluconazole |
D00322
|
|
Protamine Sulfate injection, solution 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
PROTAMINE SULFATE |
D02224
|
|
Diprivan injection, emulsion 10 mg/mL (NDA)
|
Fresenius Kabi USA, LLC |
PROPOFOL |
D00549
|
|
Baclofen injection, solution 1000 ug/mL (ANDA)
|
Sagent Pharmaceuticals |
Baclofen |
D00241
|
|
Omeprazole/Bicarbonate capsule, gelatin coated 40 mg (ANDA)
|
Westminster Pharmaceuticals, LLC |
Omeprazole and Sodium Bicarbonate |
D11706
|
|
CHLORTHALIDONE tablet 25 mg (ANDA)
|
Bryant Ranch Prepack |
chlorthalidone |
D00272
|
Progesterone capsule 100 mg (ANDA)
Progesterone capsule 200 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc |
Progesterone |
D00066
|
|
Nitrofurantoin capsule 100 mg (ANDA)
|
Micro Labs Limited |
Nitrofurantoin |
D00439
|
|
Colestipol Hydrochloride tablet 1 g (NDA AUTHORIZED GENERIC)
|
Mylan Pharmaceuticals Inc. |
Colestipol Hydrochloride |
D02113
|
|
Methenamine Hippurate tablet 1000 mg (ANDA)
|
Micro Labs Limited |
Methenamine Hippurate |
D00855
|
|
BACLOFEN tablet 10 mg (ANDA)
|
PD-Rx Pharmaceuticals, Inc. |
BACLOFEN |
D00241
|
|
Fluconazole tablet 200 mg (ANDA)
|
Preferred Pharmaceuticals Inc. |
Fluconazole |
D00322
|
TRAZODONE HYDROCHLORIDE tablet 50 mg (ANDA)
TRAZODONE HYDROCHLORIDE tablet 100 mg (ANDA)
TRAZODONE HYDROCHLORIDE tablet 150 mg (ANDA)
TRAZODONE HYDROCHLORIDE tablet 300 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
trazodone hydrochloride |
D00820
|