Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
As of Nov 13, 2026, NDA 11683 (Thiotepa), held by Immunex, was first approved by FDA on Mar 9, 1959, with 9 approved supplements and 0 published complete response letters.
First approved: Mar 9, 1959
Review: Priority
Supplements approved: 9
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 10 submissions below
Date
Submission
Status
Documents
Mar 9, 1959
Original applicationNew molecular entity · Priority review
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
