Details for New Drug Application (NDA): 211029
✉ Email this page to a colleague
The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. Ten suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 211029
Tradename: | BROMFENAC SODIUM |
Applicant: | Gland Pharma Ltd |
Ingredient: | bromfenac sodium |
Patents: | 0 |
Pharmacology for NDA: 211029
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 211029
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 211029 | ANDA | Gland Pharma Limited | 68083-313 | 68083-313-01 | 1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) / 1.7 mL in 1 BOTTLE, DROPPER |
BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 211029 | ANDA | Fosun Pharma USA Inc. | 72266-142 | 72266-142-01 | 1 BOTTLE, DROPPER in 1 CARTON (72266-142-01) / 1.7 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.09% ACID | ||||
Approval Date: | Mar 17, 2020 | TE: | AT2 | RLD: | No |
Complete Access Available with Subscription