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FDA ANDA · ANDA090768

DONEPEZIL HYDROCHLORIDE

Sponsor: JUBILANT GENERICS

APPLICATION
ANDA090768
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-31
LATEST ACTION
2021-05-04
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

2021-05-04Labeling · Supplement 12 · standardAP
2016-07-15Labeling · Supplement 4 · standardAP
2016-07-15Labeling · Supplement 7 · standardAP
2011-05-31OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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