Brimonidine tartrate and Timolol maleate

FDA Drug Profile — Brimonidine tartrate and Timolol maleate, BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

Brimonidine tartrate and Timolol maleate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Brimonidine tartrate and Timolol maleate, BRIMONIDINE TARTRATE AND TIMOLOL MALEATE. Available dosage forms: solution/ drops, solution.

Drug Details

Generic Name
Brimonidine tartrate and Timolol maleate
Brand Names
Brimonidine tartrate and Timolol maleate, BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Application Number
ANDA201949
Sponsor
NorthStar RxLLC
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS, SOLUTION
Routes
OPHTHALMIC
Active Ingredients
BRIMONIDINE TARTRATE, TIMOLOL MALEATE

Indications and Usage

1 INDICATIONS & USAGE Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day.