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FDA ANDA · ANDA078704

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Sponsor: TEVA PHARMS

APPLICATION
ANDA078704
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-28
LATEST ACTION
2025-06-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDiscontinued
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-06-17Labeling · Supplement 3 · standardAP
2009-09-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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