Details for New Drug Application (NDA): 050763
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NDA 050763 describes MITOZYTREX, which is a drug marketed by Supergen and is included in one NDA. Additional details are available on the MITOZYTREX profile page.
The generic ingredient in MITOZYTREX is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
The generic ingredient in MITOZYTREX is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 050763
| Tradename: | MITOZYTREX |
| Applicant: | Supergen |
| Ingredient: | mitomycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050763
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 14, 2002 | TE: | RLD: | Yes | |||||
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