APPLICATION
ANDA077344
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-31
LATEST ACTION
2025-03-13
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
2025-03-13Labeling · Supplement 2 · standardAP
2011-05-31OriginalAP
2010-06-29Labeling · Supplement 1AP
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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