Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Mayne Pharma Inc.
Sanofi-Aventis U.S. LLC
756003745
Pharmachemie B.V.
Sanofi-Aventis U.S. LLC
402108922
Pfanstiehl, Inc.
Sanofi-Aventis U.S. LLC
005203476
Ash Stevens Inc.
Sanofi-Aventis U.S. LLC
049265333
EUROAPI UK LIMITED
Sanofi-Aventis U.S. LLC
229522842
Genzyme Corporation
Sanofi-Aventis U.S. LLC
050424395
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clolar
Product Details
NDC Product Code
0024-5860Application Number
NDA021673Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
July 31, 2022SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
ClofarabineActive
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL