MedPath
FDA Approval

MIGLUSTAT

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 20, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Miglustat(100 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MIGLUSTAT

Product Details

NDC Product Code
43975-310
Application Number
ANDA208342
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
August 31, 2022
MiglustatActive
Code: ADN3S497AZClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
© Copyright 2025. All Rights Reserved by MedPath