Application Nr Approved Date Route Status External Links
ANDA077847 2008-10-28 Ophthalmic RX 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 (3 Total)

Name Structure Kind Function Status
1. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
2. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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