Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Almac Pharma Services Limited
Actelion Pharmaceuticals US, Inc.
233170864
Lonza AG
Actelion Pharmaceuticals US, Inc.
480007517
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zavesca
Product Details
NDC Product Code
66215-201Application Number
NDA021348Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 20, 2023SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
MiglustatActive
Code: ADN3S497AZClass: ACTIBQuantity: 100 mg in 1 1