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FDA ANDA · ANDA204831

DONEPEZIL HYDROCHLORIDE

Sponsor: UNICHEM

APPLICATION
ANDA204831
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-10
LATEST ACTION
2016-11-10
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
DONEPEZIL HYDROCHLORIDEDiscontinued
DONEPEZIL HYDROCHLORIDE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2016-11-10UNKNOWN · OriginalAP
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