ANDA 88854, held by Superpharm. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 88854 (Amitriptyline Hydrochloride), held by Superpharm, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride25MG ยท tablet;oral | Amitriptyline 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