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As of Nov 13, 2026, NDA 17783 (Glucotrol), held by Pfizer, was first approved by FDA on May 8, 1984, with 20 approved supplements and 0 published complete response letters.
First approved: May 8, 1984
Review: Standard
Supplements approved: 20
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 21 submissions below
Date
Submission
Status
Documents
May 8, 1984
Original applicationNew molecular entity · Standard review
Approved
None posted
Products
3 strengths and forms
Product
Active ingredient
Marketing
Glucotrol5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral
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
