Details for New Drug Application (NDA): 219093
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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. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 219093
| Tradename: | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
| Applicant: | Caplin |
| Ingredient: | brimonidine tartrate; timolol maleate |
| Patents: | 0 |
Pharmacology for NDA: 219093
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 219093
| 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 | 219093 | ANDA | Caplin Steriles Limited | 65145-162 | 65145-162-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPER |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | brimonidine tartrate; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 219093 | ANDA | Caplin Steriles Limited | 65145-163 | 65145-163-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 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: | Feb 25, 2025 | TE: | AB | RLD: | No | ||||
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