APPLICATION
ANDA201146
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-17
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 5MG · TABLET · ORAL
DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2023-06-07Labeling · Supplement 22 · standardAP
2020-11-13Labeling · Supplement 15 · standardAP
2016-11-08Labeling · Supplement 8 · standardAP
2014-11-06Manufacturing (CMC) · Supplement 3 · unknownAP
2013-11-07Labeling · Supplement 2 · standardAP
2012-08-17Not Applicable · 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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