Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050763
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MITOZYTREX MITOMYCIN 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/14/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50763_Mitozytrex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050763s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050763_mytozytrex.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/14/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50763_Mitozytrex_lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English