Details for New Drug Application (NDA): 216114
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NDA 216114 describes BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Apotex, Florida, Glenmark Pharms Ltd, Sandoz, Sentiss, Somerset, and Upsher Smith Labs, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the BRIMONIDINE TARTRATE AND TIMOLOL MALEATE profile page.
The generic ingredient in BRIMONIDINE TARTRATE AND TIMOLOL MALEATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
The generic ingredient in BRIMONIDINE TARTRATE AND TIMOLOL MALEATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 216114
| Tradename: | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
| Applicant: | Somerset |
| Ingredient: | brimonidine tartrate; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 216114
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 216114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 216114 | ANDA | Somerset Therapeutics, LLC | 70069-651 | 70069-651-01 | 1 BOTTLE in 1 CARTON (70069-651-01) / 5 mL in 1 BOTTLE |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 216114 | ANDA | Somerset Therapeutics, LLC | 70069-652 | 70069-652-01 | 1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.2%;EQ 0.5% BASE | ||||
| Approval Date: | Sep 10, 2024 | TE: | AB | RLD: | No | ||||
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