timolol maleate

FDA Drug Profile — timolol maleate, TIMOLOL MALEATE, Timolol Maleate, Timolol GFS

timolol maleate is listed in the FDA National Drug Code directory with 18 NDC codes, marketed under brand names including timolol maleate, TIMOLOL MALEATE, Timolol Maleate. Available dosage forms: solution/ drops, powder, solution, gel forming / drops, tablet.

Drug Details

Generic Name
timolol maleate
Brand Names
timolol maleate, TIMOLOL MALEATE, Timolol Maleate, Timolol GFS
Application Number
ANDA078771
Sponsor
Lifestar Pharma LLC
NDC Codes
18
Dosage Forms
SOLUTION/ DROPS, POWDER, SOLUTION, GEL FORMING / DROPS, TABLET
Routes
OPHTHALMIC, ORAL
Active Ingredients
TIMOLOL MALEATE

Indications and Usage

1 INDICATIONS AND USAGE Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see CLINICAL STUDIES (14)]. •Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a carbonic anhydrase inhibitor with a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. •The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)