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FDA Approval

Clolar

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 15, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clofarabine(1 mg in 1 mL)

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
0024-5860
Application Number
NDA021673
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
July 31, 2022
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL
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