Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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) | 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 | Mitomycin, Injection, Accord Healthcare, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com