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FDA Approval

Yargesa

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

FDA Approval Summary

Company
Effective Date
October 11, 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.

Yargesa

Product Details

NDC Product Code
42799-709
Application Number
ANDA209821
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 11, 2023
MiglustatActive
Code: ADN3S497AZClass: ACTIBQuantity: 100 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
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