| Product |
Company |
Generic name |
KEGG DRUG |
lamotrigine tablet, for suspension 5 mg (ANDA)
lamotrigine tablet, for suspension 25 mg (ANDA)
|
Alembic Pharmaceuticals Inc. |
lamotrigine |
D00354
|
|
Methocarbamol tablet 500 mg (ANDA)
|
ASCLEMED USA INC. |
methocarbamol |
D00402
|
|
SODIUM BICARBONATE injection, solution 84 mg/mL (ANDA)
|
Hospira, Inc. |
SODIUM BICARBONATE |
D01203
|
|
Sodium Bicarbonate injection, solution 42 mg/mL (ANDA)
|
Hospira, Inc. |
SODIUM BICARBONATE |
D01203
|
|
ropinirole tablet, film coated .5 mg (ANDA)
|
REMEDYREPACK INC. |
ropinirole |
D00784
|
|
Gefitinib tablet, film coated 250 mg (ANDA)
|
Natco Pharma USA LLC |
Gefitinib |
D01977
|
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 750 mg/20mL (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.25 g/30mL (ANDA)
Vancomycin Hydrochloride injection, powder, lyophilized, for solution 1.5 g/30mL (ANDA)
|
STERISCIENCE SPECIALTIES PRIVATE LIMITED |
Vancomycin Hydrochloride |
D00926
|
|
Rocuronium Bromide injection, solution 10 mg/mL (ANDA)
|
Hospira, Inc. |
Rocuronium Bromide |
D00765
|
|
Valacyclovir tablet 1000 mg (ANDA)
|
Redpharm Drug |
Valacyclovir |
D00398
|
|
Desonide Ointment, 0.05% ointment .5 mg/g (ANDA)
|
Encube Ethicals, Inc. |
Desonide Ointment, 0.05% |
D03696
|
|
Cleocin suppository 100 mg (NDA)
|
Pharmacia & Upjohn Company LLC |
clindamycin phosphate |
D01073
|
|
Tranexamic Acid tablet, film coated 650 mg (ANDA)
|
Actavis Pharma, Inc. |
Tranexamic Acid |
D01136
|
|
Lidocaine hydrochloride solution 20 mg/mL (ANDA)
|
Xttrium Laboratories, Inc. |
Lidocaine hydrochloride |
D08127
|
|
SODIUM PHOSPHATES injection, solution 276 mg/mL (ANDA)
|
Caplin Steriles Limited |
SODIUM PHOSPHATES |
|
|
Modafinil tablet 200 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Modafinil |
D01832
|
Meropenem injection 500 mg/20mL (ANDA)
Meropenem injection 1 g/20mL (ANDA)
|
BROOKS STERISCIENCE LIMITED |
Meropenem |
D02222
|
Hydrocodone Bitartrate and Acetaminophen tablet 5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 7.5 mg (ANDA)
Hydrocodone Bitartrate and Acetaminophen tablet 10 mg (ANDA)
|
Asclemed USA, Inc. |
Hydrocodone Bitartrate and Acetaminophen |
D00846
|
|
Fluocinolone Acetonide Oil oil .11 mg/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Fluocinolone Acetonide |
D01825
|
|
Lovastatin tablet 10 mg (ANDA)
|
Bryant Ranch Prepack |
Lovastatin |
D00359
|
KEVZARA injection, solution 150 mg.14mL (BLA)
KEVZARA injection, solution 200 mg.14mL (BLA)
|
Sanofi-Aventis U.S. LLC |
sarilumab |
D10161
|
Eszopiclone tablet, film coated 1 mg (ANDA)
Eszopiclone tablet, film coated 2 mg (ANDA)
Eszopiclone tablet, film coated 3 mg (ANDA)
|
Asclemed USA, Inc. |
Eszopiclone |
D02624
|
Sumatriptan tablet 25 mg (ANDA)
Sumatriptan tablet 50 mg (ANDA)
Sumatriptan tablet 100 mg (ANDA)
|
NorthStar Rx LLC |
Sumatriptan Succinate |
D00676
|
|
Jalyn capsule .5 mg (NDA)
|
Waylis Therapeutics |
DUTASTERIDE and TAMSULOSIN HYDROCHLORIDE |
D11389
|
Triamcinolone Acetonide ointment .25 mg/g (ANDA)
Triamcinolone Acetonide ointment 1 mg/g (ANDA)
|
Asclemed USA, Inc. |
triamcinolone acetonide |
D00983
|
Olanzapine tablet, orally disintegrating 5 mg (ANDA)
Olanzapine tablet, orally disintegrating 10 mg (ANDA)
Olanzapine tablet, orally disintegrating 15 mg (ANDA)
Olanzapine tablet, orally disintegrating 20 mg (ANDA)
|
Macleods Pharmaceuticals Limited |
Olanzapine |
D00454
|
|
Triamcinolone Acetonide injection, suspension 400 mg0mL (ANDA)
|
REMEDYREPACK INC. |
Triamcinolone Acetonide |
D00983
|
|
Etodolac capsule 200 mg (ANDA)
|
Bryant Ranch Prepack |
Etodolac |
D00315
|
|
QUZYTTIR injection 10 mg/mL (NDA)
|
TerSera Therapeutics LLC |
Cetirizine Hydrochloride |
D00664
|
|
Fluocinolone Acetonide Oil oil .11 mg/mL (ANDA)
|
Rising Pharma Holdings, Inc. |
Fluocinolone Acetonide |
D01825
|
|
Adapalene and benzoyl peroxide gel 3 mg/g (ANDA)
|
Teva Pharmaceuticals, Inc. |
Adapalene and benzoyl peroxide |
D10792
|
|
Enjaymo injection, solution, concentrate 50 mg/mL (BLA)
|
Recordati Rare Diseases, Inc. |
sutimlimab-jome |
D11530
|
|
Cimetidine tablet, film coated 300 mg (ANDA)
|
Bryant Ranch Prepack |
Cimetidine |
D00295
|
Clozapine tablet 25 mg (ANDA)
Clozapine tablet 100 mg (ANDA)
Clozapine tablet 200 mg (ANDA)
|
Safecor Health LLC |
clozapine |
D00283
|
Doxercalciferol capsule .5 ug (ANDA)
Doxercalciferol capsule 1 ug (ANDA)
Doxercalciferol capsule 2.5 ug (ANDA)
|
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
Doxercalciferol |
D01009
|
|
Ciprofloxacin tablet 500 mg (ANDA)
|
Direct_Rx |
Ciprofloxacin |
D02216
|
|
budesonide capsule 3 mg (NDA)
|
Padagis US LLC |
budesonide |
D00246
|
Divalproex Sodium tablet, film coated, extended release 250 mg (ANDA)
Divalproex Sodium tablet, film coated, extended release 500 mg (ANDA)
|
Safecor Health, LLC |
divalproex sodium |
D00304
|
|
INDOMETHACIN capsule, extended release 75 mg (ANDA)
|
Bryant Ranch Prepack |
Indomethacin |
D00141
|
|
NORTRIPTYLINE HYDROCHLORIDE capsule 50 mg (ANDA)
|
DIRECT RX |
NORTRIPTYLINE HYDROCHLORIDE |
D00816
|
|
Pioglitazone tablet 45 mg (ANDA)
|
Bryant Ranch Prepack |
Pioglitazone |
D00945
|