FDA Approval Activities for this Drug…

Blenoxane (bleomycin sulfate) Injection, USP, Bristol-Myers Squibb Company NDA 50-443/S-035 3/21/03 3/26/03 3/26/03 Bleomycin for Injection USP, 15 units base/vial & 30 units base/vial, Bedford ANDA 65-042 10/17/01 4/10/03 Bleomycin for Injection USP, 15 units base/vial & 30 units base/vial, Gensia Sicor ANDA 65-033 6/27/00 10/30/00 Bleomycin for Injection USP, 15 units base/vial & 30 units base/vial, Faulding Pharmaceutical Co. ANDA 65-031 BLEOMYCIN SULFATE Injection 15 UNITS BASE/VIAL BLEOMYCIN Bedford 065042 BLEOMYCIN SULFATE Injection 30 UNITS BASE/VIAL BLEOMYCIN Bedford 050443 BLEOMYCIN SULFATE Injection 15 UNITS BASE/VIAL BLENOXANE BRISTOL MYERS SQUIBB 050443 BLEOMYCIN SULFATE Injection 30 UNITS BASE/VIAL BLENOXANE BRISTOL MYERS SQUIBB 065031 BLEOMYCIN SULFATE Injection 15 UNITS BASE/VIAL BLEOMYCIN Faulding 065031 BLEOMYCIN SULFATE Injection 30 UNITS BASE/VIAL BLEOMYCIN Faulding 065033 BLEOMYCIN SULFATE Injection 15 UNITS BASE/VIAL BLEOMYCIN Gensia Sicor 064084 BLEOMYCIN SULFATE Injection 15 UNITS BASE/VIAL BLEOMYCIN SULFATE Gensia Sicor 064084 BLEOMYCIN SULFATE Injection 30 UNITS BASE/VIAL BLEOMYCIN SULFATE Gensia Sicor 065033 BLEOMYCIN SULFATE Injection 30 UNITS BASE/VIAL BLEOMYCIN Gensia Sicor Blenoxane (bleomycin sulfate) for injection, Bristol-Myers Squibb, Labeling Revision

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