Details for New Drug Application (NDA): 211914
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NDA 211914 describes BRINZOLAMIDE, which is a drug marketed by Bausch And Lomb, Padagis Us, and Watson Labs Inc, and is included in three NDAs. It is available from five suppliers. Additional details are available on the BRINZOLAMIDE profile page.
The generic ingredient in BRINZOLAMIDE is brinzolamide. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the brinzolamide profile page.
The generic ingredient in BRINZOLAMIDE is brinzolamide. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the brinzolamide profile page.
Summary for 211914
| Tradename: | BRINZOLAMIDE |
| Applicant: | Padagis Us |
| Ingredient: | brinzolamide |
| Patents: | 0 |
Pharmacology for NDA: 211914
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Suppliers and Packaging for NDA: 211914
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRINZOLAMIDE | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 211914 | ANDA | Padagis US LLC | 0574-4012 | 0574-4012-10 | 1 BOTTLE in 1 CARTON (0574-4012-10) / 10 mL in 1 BOTTLE |
| BRINZOLAMIDE | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 211914 | ANDA | Padagis US LLC | 0574-4012 | 0574-4012-15 | 1 BOTTLE in 1 CARTON (0574-4012-15) / 15 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 1% | ||||
| Approval Date: | Jul 28, 2023 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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