Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
As of Nov 13, 2026, NDA 18067 (Cinobac), held by Lilly, was first approved by FDA on Jun 13, 1980, with 27 approved supplements and 0 published complete response letters.
First approved: Jun 13, 1980
Review: Standard
Supplements approved: 27
Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 28 submissions below
Date
Submission
Status
Documents
Jun 13, 1980
Original applicationNew molecular entity · 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
