Details for New Drug Application (NDA): 201949
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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. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 201949
Tradename: | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
Applicant: | Florida |
Ingredient: | brimonidine tartrate; timolol maleate |
Patents: | 0 |
Pharmacology for NDA: 201949
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 201949
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 | 201949 | ANDA | Actavis Pharma, Inc. | 0591-2422 | 0591-2422-12 | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-12) / 15 mL in 1 BOTTLE, DROPPER |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 201949 | ANDA | Actavis Pharma, Inc. | 0591-2422 | 0591-2422-79 | 1 BOTTLE, DROPPER in 1 CARTON (0591-2422-79) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.2%;EQ 0.5% BASE | ||||
Approval Date: | Oct 4, 2022 | TE: | AB | RLD: | No |
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