FDA Approval Activities for this Drug…

Mitomycin Injection, 5 mg/vial and 20 mg/vial SuperGen ANDA 64-144 4/30/98 5/6/98 Mitomycin for Injection USP, 5 mg/vial and 20 mg/vial. ESI Lederle ANDA 64-180 12/23/99 12/27/99 Mitozytrex (Mitomycin) Injection, USP, SuperGen, NDA 50-763 Mytozytrex (Mitomycin Injection) Company: SuperGen NDA 50-763 MITOMYCIN Injection 20MG/VIAL MITOMYCIN Baxter 064180 MITOMYCIN Injection 5MG/VIAL MITOMYCIN Baxter 064117 MITOMYCIN Injection 20MG/VIAL MITOMYCIN Bedford 064117 MITOMYCIN Injection 5MG/VIAL MITOMYCIN Bedford 062336 MITOMYCIN Injection 20MG/VIAL MUTAMYCIN BRISTOL MYERS 062336 MITOMYCIN Injection 40MG/VIAL MUTAMYCIN BRISTOL MYERS 062336 MITOMYCIN Injection 5MG/VIAL MUTAMYCIN BRISTOL MYERS 064106 MITOMYCIN Injection 20MG/VIAL MITOMYCIN Faulding 064144 MITOMYCIN Injection 20MG/VIAL MITOMYCIN SUPERGEN 064144 MITOMYCIN Injection 5MG/VIAL MITOMYCIN SUPERGEN 050763 MITOMYCIN Injection 5MG/VIAL MYTOZYTREX SUPERGEN

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