The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Clofarabine (NDC 49315-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 (1f610666 20ee 4e77 Baa3 Ac6dabbff314 01)
NDC 49315-003-06
Clofarabine Injection 20 mg/20 mL (1 mg/mL)
Must Be Diluted Prior To Intravenous Use
Rx only Single-Dose Vial
Vial Label (1f610666 20ee 4e77 Baa3 Ac6dabbff314 02)
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