CLOLAR Solution for injection Ref.[10776] Active ingredients: Clofarabine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Clolar (clofarabine) injection contains clofarabine, a purine nucleoside metabolic inhibitor. The chemical name of clofarabine is 2-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine. Its molecular formula is C10H11ClFN5O3 with a molecular weight of 303.68 Daltons.

The molecular structure of clofarabine is:

Clolar (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.

Dosage Forms and Strengths

Injection: 20 mg/20 mL (1 mg/mL) clear solution in single-dose vial.

How Supplied

Clolar (clofarabine) injection is supplied in single-dose flint vials containing 20 mg of clofarabine in 20 mL of solution. Each box contains one Clolar vial (NDC 0024-5860-01). The 20-mL flint vials contain 20 mL (20 mg) of solution. The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, is preservative-free, and is free from foreign matter.

Manufactured by: Teva Pharmachemie, Swensweg 5, Haarlem, The Netherlands

Manufactured for: Genzyme Corporation, Cambridge, MA 02142

Drugs

Drug Countries
CLOLAR Canada, United States

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