ANDA 88697, held by Par Pharm. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 88697 (Amitriptyline Hydrochloride), held by Par Pharm, was first approved by FDA on Sep 25, 1984, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 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
