NDA 13927, held by Lederle. Quinethazone; Reserpine.
As of Nov 14, 2026, NDA 13927 (Hydromox R), held by Lederle, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydromox R50MG;0.125MG ยท tablet;oral | Quinethazone; Reserpine | 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