| Product |
Company |
Generic name |
KEGG DRUG |
|
SILVADENE cream 10 mg/g (NDA)
|
Pfizer Laboratories Div Pfizer Inc |
silver sulfadiazine |
D00433
|
|
Melphalan Hydrochloride kit (ANDA)
|
Dr.Reddy's Laboratories Inc |
Melphalan Hydrochloride |
D08173
|
Erythromycin tablet, film coated 250 mg (ANDA)
Erythromycin tablet, film coated 500 mg (ANDA)
|
Orange Pharmaceuticals USA LLC |
Erythromycin |
D00140
|
Silodosin capsule 4 mg (ANDA)
Silodosin capsule 8 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
Silodosin |
D01965
|
|
Ketorolac Tromethamine injection, solution 30 mg/mL (ANDA)
|
Proficient Rx LP |
ketorolac tromethamine |
D00813
|
Baclofen injection, solution 500 ug/mL (ANDA)
Baclofen injection, solution 2000 ug/mL (ANDA)
|
Sagent Pharmaceuticals |
Baclofen |
D00241
|
|
Montelukast Sodium tablet, chewable 4 mg (ANDA)
|
Proficient Rx LP |
Montelukast Sodium |
D00529
|
Solifenacin Succinate tablet 5 mg (ANDA)
Solifenacin Succinate tablet 10 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
Solifenacin Succinate |
D01269
|
neostigmine methylsulfate injection .5 mg/mL (ANDA)
neostigmine methylsulfate injection 1 mg/mL (ANDA)
|
Camber Pharmaceuticals Inc. |
neostigmine methylsulfate |
D00998
|
|
Baclofen injection, solution 50 ug/mL (ANDA)
|
Sagent Pharmaceuticals |
Baclofen |
D00241
|
Dimethyl Fumarate capsule, delayed release 120 mg (ANDA)
Dimethyl Fumarate capsule, delayed release 240 mg (ANDA)
Dimethyl Fumarate kit (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED |
Dimethyl fumarate |
D03846
|
|
CIDOFOVIR injection, solution 75 mg/mL (ANDA)
|
Mylan Institutional LLC |
Cidofovir Anhydrous |
D00273
|
|
LACTULOSE solution 10 g5mL (ANDA)
|
Lannett Company, Inc. |
LACTULOSE |
D00352
|
|
vancomycin hydrochloride injection, powder, lyophilized, for solution 5 g00mL (ANDA)
|
Mylan Institutional LLC |
vancomycin hydrochloride |
D00926
|
|
Letrozole tablet, film coated 2.5 mg (ANDA)
|
Proficient Rx LP |
Letrozole |
D00964
|
|
Cyanocobalamin injection, solution 1000 ug/mL (ANDA)
|
Asclemed USA, Inc. |
CYANOCOBALAMIN |
D00166
|
|
Cytarabine injection, solution 100 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
CYTARABINE |
D00168
|
|
Eszopiclone tablet, film coated 2 mg (ANDA)
|
St Mary's Medical Park Phcy |
Eszopiclone |
D02624
|
|
Butalbital and Acetaminophen tablet 300 mg (ANDA)
|
Oceanside Pharmaceuticals |
Butalbital and Acetaminophen tablets |
D11561
|
SILODOSIN capsule 4 mg (ANDA)
SILODOSIN capsule 8 mg (ANDA)
|
Novadoz Pharmaceuticals LLC |
SILODOSIN |
D01965
|
|
Decitabine injection, powder, lyophilized, for solution 50 mg/20mL (ANDA)
|
Meitheal Pharmaceuticals Inc. |
Decitabine |
D03665
|
BUSPIRONE HYDROCHLORIDE tablet 5 mg (ANDA)
BUSPIRONE HYDROCHLORIDE tablet 7.5 mg (ANDA)
BUSPIRONE HYDROCHLORIDE tablet 10 mg (ANDA)
BUSPIRONE HYDROCHLORIDE tablet 15 mg (ANDA)
BUSPIRONE HYDROCHLORIDE tablet 30 mg (ANDA)
|
Aurobindo Pharma Limited |
BUSPIRONE HYDROCHLORIDE |
D00702
|
|
Propranolol Hydrochloride tablet 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
propranolol hydrochloride |
D00483
|
|
Metformin Hydrochloride tablet, extended release 500 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Metformin Hydrochloride |
D00944
|
|
Montelukast tablet, film coated 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Montelukast |
D00529
|
|
TACLONEX suspension .5 mg/g (NDA)
|
LEO Pharma Inc. |
calcipotriene and betamethasone dipropionate |
D10534
|
|
Fosaprepitant injection, powder, lyophilized, for solution 150 mg/5mL (ANDA)
|
Novadoz Pharmaceuticals LLC |
Fosaprepitant |
D06597
|
Lisinopril tablet 2.5 mg (ANDA)
Lisinopril tablet 5 mg (ANDA)
Lisinopril tablet 10 mg (ANDA)
Lisinopril tablet 20 mg (ANDA)
Lisinopril tablet 30 mg (ANDA)
Lisinopril tablet 40 mg (ANDA)
|
BluePoint Laboratories |
Lisinopril |
D00362
|
|
NOREPINEPHRINE BITARTRATE injection, solution, concentrate 1 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
NOREPINEPHRINE BITARTRATE |
D05206
|
|
MEDROXYPROGESTERONE ACETATE injection, suspension 150 mg/mL (ANDA)
|
Sun Pharmaceutical Industries, Inc. |
MEDROXYPROGESTERONE ACETATE |
D00951
|
Deferasirox tablet, for suspension 500 mg (ANDA)
Deferasirox tablet, for suspension 125 mg (ANDA)
Deferasirox tablet, for suspension 250 mg (ANDA)
|
Dr. Reddy's Laboratories Inc |
Deferasirox |
D03669
|
|
bivalirudin injection, powder, lyophilized, for suspension 250 mg (ANDA)
|
Slate Run Pharmaceuticals, LLC |
bivalirudin |
D11280
|
Metformin Hydrochloride tablet, film coated, extended release 500 mg (ANDA)
Metformin Hydrochloride tablet, film coated, extended release 1000 mg (ANDA)
|
ScieGen Pharmaceuticals, Inc. |
Metformin Hydrochloride Extended-Release Tablets |
D00944
|
|
FUROSEMIDE injection, solution 10 mg/mL (NDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
FUROSEMIDE |
D00331
|
|
FLUMAZENIL injection, solution .1 mg/mL (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
FLUMAZENIL |
D00697
|
|
(SOTRADECOL) SODIUM TETRADECYL SULFATE injection, solution 30 mg/mL (ANDA)
|
HF Acquisition Co LLC, DBA HealthFirst |
(SOTRADECOL) SODIUM TETRADECYL SULFATE |
D06882
|
Cyclobenzaprine Hydrochloride tablet, film coated 5 mg (ANDA)
Cyclobenzaprine Hydrochloride tablet, film coated 10 mg (ANDA)
|
Rising Pharma Holdings, Inc. |
Cyclobenzaprine Hydrochloride |
D00772
|
Budesonide suspension .25 mg/2mL (ANDA)
Budesonide suspension .5 mg/2mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Budesonide |
D00246
|
|
lithium carbonate capsule 300 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
lithium carbonate |
D00801
|
Budesonide suspension .25 mg/2mL (ANDA)
Budesonide suspension .5 mg/2mL (ANDA)
|
Teva Pharmaceuticals USA, Inc. |
Budesonide |
D00246
|