ANDA 89423, held by Mutual Pharm. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 89423 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on Feb 17, 1987, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride150MG ยท tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Dec 1, 1998 | Supplement 21Manufacturing | Approved | None posted |
| Oct 16, 1995 | Supplement 20Labeling | Approved | None posted |
| Dec 23, 1994 | Supplement 19Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 18Manufacturing | Approved | None posted |
| Sep 3, 1993 | Supplement 17Labeling | Approved | None posted |
| Apr 3, 1992 | Supplement 16Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 14Manufacturing | Approved | None posted |
| Jan 31, 1992 | Supplement 13Labeling | Approved | None posted |
| Dec 30, 1991 | Supplement 12Labeling | Approved | None posted |
| May 1, 1991 | Supplement 11Manufacturing | Approved | None posted |
| May 1, 1991 | Supplement 10Manufacturing | Approved | None posted |
| May 1, 1991 | Supplement 9Manufacturing | Approved | None posted |
| May 1, 1991 | Supplement 8Manufacturing | Approved | None posted |
| Feb 28, 1990 | Supplement 6Manufacturing | Approved | None posted |
| Jun 14, 1988 | Supplement 5Manufacturing | Approved | None posted |
| Feb 12, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Mar 27, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Feb 17, 1987 | 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
