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As of Nov 14, 2026, NDA 50621 (Suprax), held by Lederle, was first approved by FDA on Apr 28, 1989, with 26 approved supplements and 0 published complete response letters.
First approved: Apr 28, 1989
Review: Standard
Supplements approved: 26
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 27 submissions below
Mar 13, 2009
Supplement 20Efficacy (new indication or use) · Standard review
Approved
None posted
Mar 13, 2009
Supplement 16Efficacy (new indication or use)
Approved
None posted
Mar 13, 2009
Supplement 15Efficacy (new indication or use)
Approved
None posted
Mar 13, 2009
Supplement 14Efficacy (new indication or use)
Approved
None posted
Mar 13, 2009
Supplement 4Efficacy (new indication or use)
Approved
None posted
Feb 5, 1993
Supplement 10Efficacy (new indication or use)
Approved
None posted
Apr 28, 1989
Original applicationNew molecular entity · Standard review
Approved
None posted
Products
2 strengths and forms
Suprax200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral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
