NDA 18366, held by Savage Labs. Bentiromide.
As of Nov 13, 2026, NDA 18366 (Chymex), held by Savage Labs, was first approved by FDA on Dec 29, 1983, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 1983 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chymex500MG/7.5ML · solution;oral | Bentiromide | Discontinued |
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
