Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.