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FDA ANDA · ANDA077846

DORZOLAMIDE HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA077846
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-28
LATEST ACTION
2021-12-03
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

DORZOLAMIDE HYDROCHLORIDEDiscontinued
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-12-03Labeling · Supplement 11 · standardAP
2015-04-06Labeling · Supplement 5 · standardAP
2011-01-25Labeling · Supplement 2AP
2009-03-06Labeling · Supplement 1AP
2008-10-28OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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