Zavesca
These highlights do not include all the information needed to use ZAVESCA safely and effectively. See full prescribing information for ZAVESCA. ZAVESCA (miglustat) capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
817892d1-ee12-4632-85fc-57ccdf16d7b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 20, 2023
Manufacturers
FDA
Actelion Pharmaceuticals US, Inc.
DUNS: 002641228
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 Code66215-201
Application NumberNDA021348
Product Classification
M
Marketing Category
C73594
G
Generic Name
miglustat
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MIGLUSTATActive
Quantity: 100 mg in 1 1
Code: ADN3S497AZ
Classification: ACTIB