ANDA 87775, held by Usl Pharma. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 87775 (Amitriptyline Hydrochloride), held by Usl Pharma, was first approved by FDA on Feb 10, 1982, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 1982 | Original application | Approved | None posted |
| 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
