ANDA 88620, held by Watson Labs. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 88620 (Amitriptyline Hydrochloride), held by Watson Labs, was first approved by FDA on Mar 2, 1984, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride10MG 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
