OPFOLDA (MIGLUSTAT)
Summary
FDA approved OPFOLDA (MIGLUSTAT) by AMICUS THERAP US. NDA (New Drug) approval (Labeling) on 2024-07-25. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA215211-2
Action Date
2024-07-25
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
OPFOLDA (generic: MIGLUSTAT), CAPSULE, ORAL. Application: NDA215211
Company
Context & Analysis
AMICUS THERAP US has 2 FDA actions in our database.
Frequently Asked Questions
How often does AMICUS THERAP US have FDA actions?
AMICUS THERAP US has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA215211-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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