Details for New Drug Application (NDA): 091691
✉ Email this page to a colleague
The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 091691
Tradename: | BRIMONIDINE TARTRATE |
Applicant: | Indoco |
Ingredient: | brimonidine tartrate |
Patents: | 0 |
Pharmacology for NDA: 091691
Mechanism of Action | Adrenergic alpha-Agonists |
Medical Subject Heading (MeSH) Categories for 091691
Suppliers and Packaging for NDA: 091691
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 091691 | ANDA | Indoco Remedies Limited | 14445-400 | 14445-400-05 | 5 mg in 1 BOTTLE, PLASTIC (14445-400-05) |
BRIMONIDINE TARTRATE | brimonidine tartrate | SOLUTION/DROPS;OPHTHALMIC | 091691 | ANDA | Indoco Remedies Limited | 14445-400 | 14445-400-10 | 10 mg in 1 BOTTLE, PLASTIC (14445-400-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.2% | ||||
Approval Date: | Nov 18, 2014 | TE: | AT | RLD: | No |
Complete Access Available with Subscription