Treats major depressive disorder (MDD). NDA 218637, held by Kamat. Trazodone Hydrochloride.
As of Nov 13, 2026, NDA 218637 (Raldesy), held by Kamat, was first approved by FDA on Nov 26, 2024, with 2 approved supplements and 0 published complete response letters.
RALDESY TM is indicated for the treatment of major depressive disorder (MDD) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Raldesy10MG/ML · solution;oral | Trazodone Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Jun 24, 2025 | Supplement 3Labeling | Approved | |
| Nov 26, 2024 | Original applicationNew dosage form · Standard review | Approved |
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
