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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 23, 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
70121-1236
Application Number
ANDA208857
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 23, 2023
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
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