ANDA 85743, held by Mutual Pharm. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 85743 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on Jul 11, 1977, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride75MG ยท tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Dec 1, 1998 | Supplement 67Manufacturing | Approved | None posted |
| Oct 16, 1995 | Supplement 66Labeling | Approved | None posted |
| Dec 23, 1994 | Supplement 65Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 64Manufacturing | Approved | None posted |
| Sep 3, 1993 | Supplement 63Labeling | Approved | None posted |
| Apr 3, 1992 | Supplement 62Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 60Manufacturing | Approved | None posted |
| Jan 31, 1992 | Supplement 59Labeling | Approved | None posted |
| Dec 30, 1991 | Supplement 58Labeling | Approved | None posted |
| Feb 28, 1990 | Supplement 57Labeling | Approved | None posted |
| Feb 28, 1990 | Supplement 56Manufacturing | Approved | None posted |
| Sep 29, 1987 | Supplement 54Manufacturing | Approved | None posted |
| Sep 29, 1987 | Supplement 53Manufacturing | Approved | None posted |
| Sep 29, 1987 | Supplement 52Manufacturing | Approved | None posted |
| Mar 20, 1987 | Supplement 51Manufacturing | Approved | None posted |
| Feb 27, 1986 | Supplement 49Manufacturing | Approved | None posted |
| Feb 5, 1986 | Supplement 48Manufacturing | Approved | None posted |
| Jul 11, 1977 | 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
