Application Nr Approved Date Route Status External Links
ANDA205295 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 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) 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) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Dorzolamide Hydrochloride DORZOLAMIDE HYDROCHLORIDE ZINC1530621
2. Timolol Maleate TIMOLOL MALEATE ZINC2176

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