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FDA ANDA · ANDA078841

DONEPEZIL HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA078841
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-02
LATEST ACTION
2016-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 5MG · TABLET · ORAL
DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2016-10-04Labeling · Supplement 5 · standardAP
2014-11-03Labeling · Supplement 4 · standardAP
2013-09-20Labeling · Supplement 1 · standardAP
2013-09-20Labeling · Supplement 2 · standardAP
2011-06-02OriginalAP
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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