NDA 19578, held by US Army Walter Reed. Mefloquine Hydrochloride.
As of Nov 13, 2026, NDA 19578 (Mefloquine Hydrochloride), held by US Army Walter Reed, was first approved by FDA on May 2, 1989, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 1989 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mefloquine Hydrochloride250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Mefloquine Hydrochloride | Discontinued |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
