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As of Nov 13, 2026, NDA 16704 (Resectisol), held by B Braun, was first approved by FDA on Nov 18, 1969, with 1 approved supplement and 0 published complete response letters.
First approved: Nov 18, 1969
Review: Standard
Supplements approved: 1
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below
Date
Submission
Status
Documents
Nov 18, 1969
Original applicationNew formulation or manufacturer · Standard 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
