Yargesa
These highlights do not include all the information needed to use YARGESA safely and effectively. See full prescribing information for YARGESA. YARGESA (miglustat) capsules, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
2b371dfe-e2b0-47fe-b677-a7bde7149f87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Edenbridge Pharmaceuticals LLC.
DUNS: 948715060
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 Code42799-709
Application NumberANDA209821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Miglustat
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (9)
MIGLUSTATActive
Quantity: 100 mg in 1 1
Code: ADN3S497AZ
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT