Application Nr Approved Date Route Status External Links
ANDA203058 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 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-Timolol Maleate 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 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 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