FDA Approval Activities for this Drug…

Cladribine Injection, 1 mg/mL, 10 mL vial (tentatively Approved 8/31/99) Bedford Labs ANDA 75-405 8/31/99 9/2/99 Cladribine Injection,1 mg/mL, Bedford Labs ANDA 75-405 Leustatin (cladribine), Ortho Biotech Products, L.P. NDA 20-229/S-021 8/22/02 8/30/02 Leustatin (cladribine) Injection, Ortho Biotech Products, L.P. NDA 20-229/S-4, S-7

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