Details for New Drug Application (NDA): 216114
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The generic ingredient in BRIMONIDINE TARTRATE AND TIMOLOL MALEATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Thirteen 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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