NDA 16020, held by Endo Pharms. Amantadine Hydrochloride.
As of Nov 13, 2026, NDA 16020 (Symmetrel), held by Endo Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Symmetrel100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท capsule;oral | Amantadine Hydrochloride | DiscontinuedReference drug |
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
