APPLICATION
ANDA204609
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-19
LATEST ACTION
2019-05-20
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
2019-05-20Labeling · Supplement 2 · standardAP
2017-09-19UNKNOWN · 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.
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