Clinoril

NDA 17911, held by Merck. Sulindac.

As of Nov 13, 2026, NDA 17911 (Clinoril), held by Merck, was first approved by FDA on Sep 27, 1978, with 53 approved supplements and 0 published complete response letters.

• First approved: Sep 27, 1978
• Review: Standard
• Supplements approved: 53
• Complete response letters: 0

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