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As of Nov 14, 2026, NDA 50763 (Mitozytrex), held by Supergen, was first approved by FDA on Nov 14, 2002, with 0 approved supplements and 0 published complete response letters.
First approved: Nov 14, 2002
Review: Standard
Supplements approved: 0
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first
Date
Submission
Status
Documents
Nov 14, 2002
Original applicationNew dosage form · Standard review
Mitozytrex5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
