ANDA 86454, held by Bristol Myers Squibb. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 86454 (Amitid), held by Bristol Myers Squibb, was first approved by FDA on Oct 19, 1978, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 1978 | Original application | Approved | None posted |
| Amitid10MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitid25MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitid50MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitid75MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitid100MG · 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
