NDA 20750, held by Sanofi Aventis US. Nedocromil Sodium.
As of Nov 14, 2026, NDA 20750 (Tilade), held by Sanofi Aventis US, was first approved by FDA on Oct 1, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tilade0.5% · solution;inhalation | Nedocromil Sodium | 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
