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FDA ANDA · ANDA078201

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA078201
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-28
LATEST ACTION
2016-04-26
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

2016-04-26Labeling · Supplement 12 · standardAP
2016-04-26Labeling · Supplement 4AP
2011-02-02Labeling · Supplement 5AP
2008-10-28OriginalAP
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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