Application Nr Approved Date Route Status External Links
ANDA077847 None Ophthalmic None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dorzolamide Hydrochloride-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 Betablockers (Failed To Achieve Target Iop Determined After Multiple Measurements Over Time). The Iop-Lowering Of Dorzolamide Hydrochloride-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-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-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)

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

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