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

Indications And Usage Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 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 B.i.d. Was Slightly Less Than 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 (2 Total)

Name Structure Kind Function Status
1. 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.
2. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.

Active Ingredients ( 2 Total)

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