APPLICATION
ANDA201787
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-06-07Labeling · Supplement 16 · standardAP
2020-11-13Labeling · Supplement 10 · standardAP
2016-11-08Labeling · Supplement 3 · standardAP
2015-04-23Manufacturing (CMC) · Supplement 2 · unknownAP
2012-12-14UNKNOWN · 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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