Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Navinta LLC
130443810
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
70710-2039Application Number
ANDA219111Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 17, 2025MiglustatActive
Code: ADN3S497AZClass: ACTIBQuantity: 100 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT