APPLICATION
ANDA205269
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-27
LATEST ACTION
2019-12-30
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2019-12-30Labeling · Supplement 1 · standardAP
2018-07-27UNKNOWN · Original · standardAP
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.