APPLICATION
ANDA203034
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-30
LATEST ACTION
2025-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG · TABLET · ORAL
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2025-04-02Labeling · Supplement 10 · standardAP
2016-10-04Labeling · Supplement 1 · standardAP
2015-01-30UNKNOWN · OriginalAP
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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