Application Nr Approved Date Route Status External Links
ANDA202054 2014-09-03 Ophthalmic RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution, Usp Is Indicated For The Reduction Of Elevated Intraocular Pressure 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 Ophthalmic Solution, Usp B.i.d. Was Slightly Less Than That Seen With The Concomitant Administration Of 0.5% Timolol B.i.d. And 2.0% Dorzolamide T.i.d. (see Clinical Pharmacology, Clinical Studies ).

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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