Details for New Drug Application (NDA): 215230
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NDA 215230 describes BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Apotex, Caplin, Glenmark Pharms Ltd, Regcon Holdings, Sandoz, Sentiss, Somerset, and Upsher Smith Labs, and is included in ten NDAs. It is available from thirteen 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 215230
| Tradename: | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
| Applicant: | Alembic |
| Ingredient: | brimonidine tartrate; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 215230
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 215230
| 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 | 215230 | ANDA | Alembic Pharmaceuticals Limited | 46708-706 | 46708-706-05 | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 215230 | ANDA | Alembic Pharmaceuticals Limited | 46708-706 | 46708-706-10 | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 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: | Aug 25, 2023 | TE: | AB | RLD: | No | ||||
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