Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Mayne Pharma International Pty Ltd.
Winthrop U.S, a business of sanofi-aventis U.S. LLC
756003745
Genzyme Corporation
Winthrop U.S, a business of sanofi-aventis U.S. LLC
050424395
Pharmachemie B.V.
Winthrop U.S, a business of sanofi-aventis U.S. LLC
402108922
Pfanstiehl, Inc.
Winthrop U.S, a business of sanofi-aventis U.S. LLC
005203476
EUROAPI UK LIMITED
Winthrop U.S, a business of sanofi-aventis U.S. LLC
229522842
Ash Stevens Inc.
Winthrop U.S, a business of sanofi-aventis U.S. LLC
049265333
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clofarabine
Product Details
NDC Product Code
0955-1746Application Number
NDA021673Marketing Category
NDA authorized generic (C73605)Route of Administration
INTRAVENOUSEffective Date
December 7, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
ClofarabineActive
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT