| Product |
Company |
Generic name |
KEGG DRUG |
|
Ketoconazole cream 20 mg/g (ANDA)
|
Encube Ethicals Private Limited
|
Ketoconazole Cream, 2%
|
D00351
|
|
Clindamycin Phosphate gel 1 g0mL (NDA AUTHORIZED GENERIC)
|
Oceanside Pharmaceuticals
|
Clindamycin Phosphate
|
D01073
|
|
Bepotastine Besilate solution/ drops 15 mg/mL (NDA AUTHORIZED GENERIC)
|
Bausch & Lomb Incorporated
|
bepotastine besilate
|
D01654
|
Lamotrigine tablet, extended release 300 mg (ANDA)
Lamotrigine tablet, extended release 25 mg (ANDA)
Lamotrigine tablet, extended release 50 mg (ANDA)
Lamotrigine tablet, extended release 100 mg (ANDA)
Lamotrigine tablet, extended release 200 mg (ANDA)
Lamotrigine tablet, extended release 250 mg (ANDA)
|
Dr.Reddy's Laboratories Limited
|
Lamotrigine
|
D00354
|
|
Dorzolamide Hydrochloride and Timolol Maleate solution/ drops 20 mg/mL (ANDA)
|
Aurobindo Pharma Limited
|
Dorzolamide Hydrochloride and Timolol Maleate
|
D08493
|
PROPAFENONE HYDROCHLORIDE capsule, extended release 225 mg (ANDA)
PROPAFENONE HYDROCHLORIDE capsule, extended release 325 mg (ANDA)
PROPAFENONE HYDROCHLORIDE capsule, extended release 425 mg (ANDA)
|
Rising Pharma Holdings, Inc.
|
PROPAFENONE HYDROCHLORIDE
|
D00640
|
Methocarbamol tablet 500 mg (ANDA)
Methocarbamol tablet 750 mg (ANDA)
|
Camber Pharmaceuticals, Inc.
|
Methocarbamol
|
D00402
|
|
Prednisolone Sodium Phosphate solution 5 mg/5mL (ANDA)
|
Pharmaceutical Associates, Inc.
|
Prednisolone Sodium Phosphate
|
D00981
|
|
Tadalafil tablet 20 mg (ANDA)
|
Aurobindo Pharma Limited
|
Tadalafil
|
D02008
|
Desmopressin Acetate tablet .1 mg (NDA)
Desmopressin Acetate tablet .2 mg (NDA)
|
Amring Pharmaceuticals Inc.
|
Desmopressin Acetate
|
D02235
|
|
Dexamethasone Sodium Phosphate injection, solution 10 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
DEXAMETHASONE SODIUM PHOSPHATE
|
D00975
|
PREGABALIN tablet, film coated, extended release 82.5 mg (ANDA)
PREGABALIN tablet, film coated, extended release 165 mg (ANDA)
PREGABALIN tablet, film coated, extended release 330 mg (ANDA)
|
MSN LABORATORIES PRIVATE LIMITED
|
PREGABALIN
|
D02716
|
|
Folic acid tablet 1 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Folic Acid
|
D00070
|
|
Meloxicam tablet 15 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Meloxicam
|
D00969
|
IBU tablet 600 mg (ANDA)
IBU tablet 800 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Ibuprofen
|
D00126
|
|
Sucralfate tablet 1 g (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Sucralfate
|
D00446
|
|
Piperacillin and Tazobactam injection, powder, lyophilized, for solution 4 g/20mL (ANDA)
|
Fresenius Kabi USA, LLC
|
Piperacillin and Tazobactam
|
D02505
|
Celecoxib capsule 50 mg (ANDA)
Celecoxib capsule 100 mg (ANDA)
Celecoxib capsule 200 mg (ANDA)
Celecoxib capsule 400 mg (ANDA)
|
Aurobindo Pharma Limited
|
Celecoxib
|
D00567
|
|
ACETAMINOPHEN AND CODEINE PHOSPHATE tablet 300 mg (ANDA)
|
Eywa Pharma Inc
|
acetaminophen and codeine phosphate
|
D02146
|
|
MONTELUKAST SODIUM tablet, chewable 5 mg (ANDA)
|
DIRECT RX
|
MONTELUKAST SODIUM
|
D00529
|
Meloxicam tablet 7.5 mg (ANDA)
Meloxicam tablet 15 mg (ANDA)
|
Aurobindo Pharma Limited
|
Meloxicam
|
D00969
|
Ramipril capsule 1.25 mg (ANDA)
Ramipril capsule 2.5 mg (ANDA)
Ramipril capsule 5 mg (ANDA)
Ramipril capsule 10 mg (ANDA)
|
Accord Healthcare Inc.
|
Ramipril
|
D00421
|
|
Clopidogrel Bisulfate tablet 75 mg (ANDA)
|
Major Pharmaceuticals
|
Clopidogrel Bisulfate
|
D00769
|
|
Cefaclor tablet, film coated, extended release 500 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Cefaclor
|
D02352
|
|
Famotidine tablet 20 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Famotidine
|
D00318
|
|
Tigecycline injection, powder, lyophilized, for solution 50 mg/5mL (ANDA)
|
Meitheal Pharmaceuticals Inc.
|
Tigecycline
|
D01079
|
Labetalol Hydrochloride tablet, film coated 100 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 200 mg (ANDA)
Labetalol Hydrochloride tablet, film coated 300 mg (ANDA)
|
Major Pharmaceuticals
|
Labetalol Hydrochloride
|
D00600
|
|
Duraclon injection, solution .1 mg/mL (NDA)
|
Mylan Institutional LLC
|
clonidine hydrochloride
|
D00604
|
|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel 50 mg/g (ANDA)
|
Encube Ethicals Private Limited
|
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
|
D10602
|
|
hydroxyzine pamoate capsule 25 mg (ANDA)
|
Proficient Rx LP
|
hydroxyzine pamoate
|
D01096
|
|
Tirofiban hydrochloride injection, solution 12.5 mg/250mL (ANDA)
|
Gland Pharma Limited
|
Tirofiban
|
D01029
|
|
Doxycycline injection, powder, for solution 100 mg (ANDA)
|
Hikma Pharmaceuticals USA Inc.
|
Doxycycline
|
D02129
|
|
HALOG solution 1 mg/mL (NDA)
|
Sun Pharmaceutical Industries, Inc.
|
Halcinonide Topical
|
D01308
|
|
Naprosyn suspension 125 mg/5mL (NDA)
|
Athena Bioscience, LLC
|
Naproxen
|
D00118
|
|
Dorzolamide Hydrochloride solution/ drops 20 mg/mL (ANDA)
|
Indoco Remedies Limited
|
Dorzolamide
|
D00653
|
Baclofen tablet 10 mg (ANDA)
Baclofen tablet 20 mg (ANDA)
|
Teva Pharmaceuticals USA, Inc.
|
Baclofen
|
D00241
|
|
Carac cream 5 mg/g (NDA)
|
Bausch Health US, LLC
|
fluorouracil
|
D00584
|
|
Heparin Sodium injection, solution 5000 [USP'U]/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
Heparin Sodium
|
D02112
|
|
Foscarnet Sodium injection, solution 24 mg/mL (ANDA)
|
Sagent Pharmaceuticals
|
Foscarnet Sodium
|
D02267
|
|
LAMOTRIGINE Kit kit (ANDA)
|
OWP Pharmaceuticals, Inc.
|
LAMOTRIGINE
|
D00354
|