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As of Nov 13, 2026, NDA 20059 (Adenoscan), held by Astellas, was first approved by FDA on May 18, 1995, with 14 approved supplements and 0 published complete response letters.
First approved: May 18, 1995
Review: Standard
Supplements approved: 14
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 15 submissions below
Date
Submission
Status
Documents
Aug 31, 2001
Supplement 7Efficacy (new indication or use) · Standard review
Adenoscan60MG/20ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous
Adenoscan90MG/30ML (3MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous
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
