MIGLUSTAT
These highlights do not include all the information needed to use MIGLUSTAT CAPSULES safely and effectively. See full prescribing information for MIGLUSTAT CAPSULES. MIGLUSTAT capsules, for oral useInitial U.S. Approval: 2003
Approved
Approval ID
d746749d-de15-4225-b806-59b0765d25ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MIGLUSTAT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43975-310
Application NumberANDA208342
Product Classification
M
Marketing Category
C73584
G
Generic Name
MIGLUSTAT
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (9)
MIGLUSTATActive
Quantity: 100 mg in 1 1
Code: ADN3S497AZ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT