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FDA ANDA · ANDA201998

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
ANDA201998
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-17
LATEST ACTION
2025-09-03
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

2025-09-03Labeling · Supplement 2 · standardAP
2025-09-03Labeling · Supplement 1 · standardAP
2014-12-17Not Applicable · OriginalAP
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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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