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FDA Drug information

CLOFARABINE

Read time: 1 mins
Marketing start date: 27 Apr 2024

Summary of product characteristics


Effective Time

20221018

Version

2

Spl Product Data Elements

CLOFARABINE clofarabine CLOFARABINE CLOFARABINE SODIUM CHLORIDE WATER

Application Number

ANDA204029

Brand Name

CLOFARABINE

Generic Name

clofarabine

Product Ndc

49315-003

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 49315-003-06 Rx only Clofarabine Injection 20 mg/20 mL (1 mg/mL) Must Be Diluted Prior To Intravenous Use Contains 1 (20 mL) Single-Dose Vial Sterile Carton label

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