APPLICATION
ANDA076786
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-26
LATEST ACTION
2014-08-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 10MG · TABLET · ORAL
DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2014-08-14Labeling · Supplement 6 · standardAP
2011-02-16Labeling · Supplement 1AP
2011-02-16Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.