Application Nr Approved Date Route Status External Links
ANDA207630 None Ophthalmic None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution Preservative Free 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 (14.1) ]. Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution Preservative Free 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)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Comments