Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
EUROAPI Hungary Ltd.
Sanofi-Aventis U.S. LLC
402388457
Alcami Carolinas Corporation
Sanofi-Aventis U.S. LLC
831351445
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexinidazole
Product Details
NDC Product Code
0024-4512Application Number
NDA214429Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 4, 2023POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FexinidazoleActive
Code: 306ERL82IRClass: ACTIBQuantity: 600 mg in 1 1