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OPFOLDA (MIGLUSTAT) — FDA Approval NDA215211 (AMICUS THERAP US)

OPFOLDA (MIGLUSTAT) — FDA Approval NDA215211 (AMICUS THERAP US) is one of 9,000 drug approvals in the DrugApprovals dataset. Key details — Brand name: OPFOLDA; Active ingredients: MIGLUSTAT; Application number: NDA215211.

Brand nameOPFOLDA
Active ingredientsMIGLUSTAT
Application numberNDA215211
SponsorAMICUS THERAP US
Dosage formCAPSULE
RouteORAL
Marketing statusPrescription
Products in application1
First approval date20230928
SourceopenFDA Drugs@FDA

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