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FDA NDA · NDA215211

OPFOLDA

miglustat

Sponsor: AMICUS THERAP US

APPLICATION
NDA215211
TYPE
NDA
ORIGINAL APPROVAL
2023-09-28
LATEST ACTION
2024-07-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

OPFOLDA · ReferencePrescription
MIGLUSTAT 65MG · CAPSULE · ORAL

Approval history

2024-07-25Labeling · Supplement 2 · standardLetterAP
2023-09-28Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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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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