ANDA 85744, held by Mutual Pharm. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 85744 (Amitriptyline Hydrochloride), held by Mutual Pharm, was first approved by FDA on Jun 21, 1977, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amitriptyline Hydrochloride10MG ยท tablet;oral | Amitriptyline Hydrochloride | Discontinued |
| Dec 1, 1998 | Supplement 78Manufacturing | Approved | None posted |
| Oct 16, 1995 | Supplement 77Labeling | Approved | None posted |
| Dec 23, 1994 | Supplement 76Manufacturing | Approved | None posted |
| Oct 11, 1994 | Supplement 75Manufacturing | Approved | None posted |
| Sep 3, 1993 | Supplement 74Labeling | Approved | None posted |
| Apr 3, 1992 | Supplement 71Manufacturing | Approved | None posted |
| Apr 3, 1992 | Supplement 73Manufacturing | Approved | None posted |
| Jan 31, 1992 | Supplement 70Labeling | Approved | None posted |
| Dec 30, 1991 | Supplement 69Labeling | Approved | None posted |
| Feb 28, 1990 | Supplement 67Manufacturing | Approved | None posted |
| Feb 28, 1990 | Supplement 68Labeling | Approved | None posted |
| Feb 12, 1988 | Supplement 66Manufacturing | Approved | None posted |
| Mar 20, 1987 | Supplement 61Manufacturing | Approved | None posted |
| Mar 5, 1986 | Supplement 57Manufacturing | Approved | None posted |
| Mar 5, 1986 | Supplement 59Manufacturing | Approved | None posted |
| Dec 27, 1985 | Supplement 58Manufacturing | Approved | None posted |
| Jun 21, 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
