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As of Nov 13, 2026, NDA 20682 (Glyset), held by Pfizer, was first approved by FDA on Dec 18, 1996, with 7 approved supplements and 0 published complete response letters.
First approved: Dec 18, 1996
Review: Standard
Supplements approved: 7
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 8 submissions below
Date
Submission
Status
Documents
Aug 16, 1999
Supplement 1Efficacy (new indication or use) · 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
