APPLICATION
ANDA203907
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-29
LATEST ACTION
2020-08-11
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
2020-08-11Labeling · Supplement 12 · standardAP
2015-12-01Labeling · Supplement 5 · standardAP
2014-10-29UNKNOWN · 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.
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.