ANDA 40218, held by Ph Health. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 40218 (Amitriptyline Hydrochloride), held by Ph Health, was first approved by FDA on Sep 11, 1997, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 1997 | Original application | Approved | None posted |
| Amitriptyline Hydrochloride10MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitriptyline Hydrochloride25MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitriptyline Hydrochloride50MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitriptyline Hydrochloride75MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitriptyline Hydrochloride100MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Amitriptyline Hydrochloride150MG · tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Jun 24, 2025 | Supplement 38Labeling · Standard review | Approved | None posted |
| Apr 25, 2016 | Supplement 23Labeling · Standard review | Approved | None posted |
| Jul 17, 2014 | Supplement 19Labeling · Standard review | Approved | None posted |
| Apr 26, 2010 | Supplement 15Labeling | Approved | None posted |
| Nov 21, 2007 | Supplement 14Labeling | Approved | None posted |
| Jun 29, 2007 | Supplement 12Labeling | Approved | None posted |
| Oct 6, 2005 | Supplement 9Labeling | Approved | None posted |
| Aug 3, 2005 | Supplement 8Labeling | Approved | None posted |
| Mar 26, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Sep 11, 1997 | 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
