Details for New Drug Application (NDA): 214987
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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 214987
Tradename: | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | brimonidine tartrate; timolol maleate |
Patents: | 0 |
Pharmacology for NDA: 214987
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 214987
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 | 214987 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-281 | 68462-281-32 | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER |
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 214987 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-281 | 68462-281-69 | 1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 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: | May 16, 2024 | TE: | AB | RLD: | No |
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