Details for New Drug Application (NDA): 206027
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NDA 206027 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 206027
| Tradename: | BROMFENAC SODIUM |
| Applicant: | Lupin Ltd |
| Ingredient: | bromfenac sodium |
| Patents: | 0 |
Pharmacology for NDA: 206027
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 206027
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BROMFENAC SODIUM | bromfenac sodium | SOLUTION/DROPS;OPHTHALMIC | 206027 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-433 | 68180-433-02 | 1 BOTTLE, DROPPER in 1 CARTON (68180-433-02) / 3 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.07% ACID | ||||
| Approval Date: | Nov 22, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 6, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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