ANDA 87616, held by Vangard. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 87616 (Amitriptyline Hydrochloride), held by Vangard, was first approved by FDA on Feb 8, 1982, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride50MG ยท tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Mar 18, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Feb 8, 1982 | Original application | Approved | None posted |
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
