ANDA 85749, held by Roche. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 85749 (Endep), held by Roche, was not approved, with 0 approved supplements and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Endep40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท concentrate;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |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
