Details for New Drug Application (NDA): 214340
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NDA 214340 describes BROMFENAC SODIUM, which is a drug marketed by Alembic, Amneal, Amring Pharms, Apotex, Chartwell Rx, Coastal Pharms, Eugia Pharma, Gland Pharma Ltd, Lupin Ltd, Rising, and Sentiss, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the BROMFENAC SODIUM profile page.
The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
The generic ingredient in BROMFENAC SODIUM is bromfenac sodium. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.
Summary for 214340
| Tradename: | BROMFENAC SODIUM |
| Applicant: | Alembic |
| Ingredient: | bromfenac sodium |
| Patents: | 0 |
Pharmacology for NDA: 214340
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 214340
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 214340 | ANDA | Alembic Pharmaceuticals Limited | 46708-583 | 46708-583-03 | 1 BOTTLE in 1 CARTON (46708-583-03) / 3 mL in 1 BOTTLE |
| BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 214340 | ANDA | Alembic Pharmaceuticals Inc. | 62332-583 | 62332-583-03 | 1 BOTTLE in 1 CARTON (62332-583-03) / 3 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.07% ACID | ||||
| Approval Date: | Jul 8, 2024 | TE: | AB | RLD: | No | ||||
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