NDA 12248, held by Wyeth Ayerst. Phendimetrazine Tartrate.
As of Nov 13, 2026, NDA 12248 (Plegine), held by Wyeth Ayerst, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Plegine35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท tablet;oral | Phendimetrazine Tartrate | Discontinued |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
