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FDA Approval

clofarabine

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

FDA Approval Summary

Company
Effective Date
August 10, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clofarabine(1 mg in 1 mL)

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
67457-546
Application Number
ANDA208860
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
March 24, 2020
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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