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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
Fosun Pharma USA Inc.
DUNS: 080920998
Effective Date
February 15, 2023
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
72266-108
Application Number
ANDA207831
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
February 15, 2023
Code: 762RDY0Y2HClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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