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Active ingredient

Dorzolamide

15 finished FDA listings contain Dorzolamide as their only active ingredient; 22 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
DORZOLAMIDE HYDROCHLORIDE
Dosage forms
Solution, Solution/ Drops
Routes
Ophthalmic
Manufacturers / labelers
14
Strengths listed
20 mg/ml
Brand names in FDA listings
Dorzolamide Hydrochloride, Dorzolamide Hydrochloride Ophthalmic, Dorzolamide Hydrochloride Ophthalmic Solution

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 60207

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 078395RUBICON RESEARCH2008-10-281
ANDA 078981SANDOZ2009-04-131
ANDA 090143BAUSCH AND LOMB2009-06-252
ANDA 202053REGCON HOLDINGS2014-09-112
ANDA 205294FDC LTD2019-01-241
ANDA 212639ALEMBIC2019-08-092
ANDA 204778MICRO LABS2019-11-082
ANDA 215660GLAND2022-01-273
ANDA 215004SOMERSET THERAPS LLC2025-02-111

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.