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As of Nov 14, 2026, NDA 17247 (Sanorex), held by Novartis, was first approved by FDA on Jun 14, 1973, with 25 approved supplements and 0 published complete response letters.
First approved: Jun 14, 1973
Review: Standard
Supplements approved: 25
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 26 submissions below
Date
Submission
Status
Documents
Jun 14, 1973
Original applicationNew molecular entity · Standard review
Approved
None posted
Products
2 strengths and forms
Sanorex1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral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
