Relieves symptoms of depression. ANDA 85968, held by Sandoz. Amitriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 85968 (Amitriptyline Hydrochloride), held by Sandoz, was first approved by FDA on Nov 29, 1977, with 41 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 1977 | Original application | Approved | None posted |
| Amitriptyline Hydrochloride50MG · tablet;oral | Amitriptyline Hydrochloride | RxReference drug |
| Amitriptyline Hydrochloride25MG · tablet;oral | Amitriptyline Hydrochloride | RxReference drug |
| Amitriptyline Hydrochloride100MG · tablet;oral | Amitriptyline Hydrochloride | RxReference drug |
| Amitriptyline Hydrochloride10MG · tablet;oral | Amitriptyline Hydrochloride | RxReference drug |
| Amitriptyline Hydrochloride150MG · tablet;oral | Amitriptyline Hydrochloride | RxReference drug |
| Amitriptyline Hydrochloride75MG · tablet;oral | Amitriptyline Hydrochloride | RxReference drug |
| Jun 24, 2025 | Supplement 112Labeling · Standard review | Approved | |
| Apr 25, 2016 | Supplement 98Labeling · Standard review | Approved | |
| Jul 17, 2014 | Supplement 96Labeling · Standard review | Approved | |
| Nov 13, 2007 | Supplement 90Labeling | Approved | None posted |
| Jun 29, 2007 | Supplement 89Labeling | Approved | None posted |
| Jun 9, 2005 | Supplement 87Labeling | Approved | None posted |
| Dec 16, 2002 | Supplement 86Manufacturing | Approved | None posted |
| Jun 25, 2001 | Supplement 85Labeling | Approved | None posted |
| Mar 23, 2001 | Supplement 84Manufacturing | Approved | None posted |
| Aug 7, 2000 | Supplement 83Labeling | Approved | None posted |
| May 5, 1999 | Supplement 82Manufacturing | Approved | None posted |
| May 28, 1998 | Supplement 81Manufacturing | Approved | None posted |
| Nov 18, 1996 | Supplement 80Manufacturing | Approved | None posted |
| Apr 17, 1996 | Supplement 79Manufacturing | Approved | None posted |
| Apr 10, 1995 | Supplement 78Labeling | Approved | None posted |
| Feb 1, 1995 | Supplement 77Manufacturing | Approved | None posted |
| Aug 27, 1993 | Supplement 76Labeling | Approved | None posted |
| Dec 15, 1992 | Supplement 75Labeling | Approved | None posted |
| Jul 17, 1987 | Supplement 74Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 69Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 68Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 67Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 66Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 65Manufacturing | Approved | None posted |
| Jul 17, 1987 | Supplement 64Manufacturing | Approved | None posted |
| Apr 27, 1987 | Supplement 73Manufacturing | Approved | None posted |
| Apr 27, 1987 | Supplement 72Manufacturing | Approved | None posted |
| Apr 27, 1987 | Supplement 71Manufacturing | Approved | None posted |
| Apr 27, 1987 | Supplement 70Manufacturing | Approved | None posted |
| Mar 12, 1985 | Supplement 54Manufacturing | Approved | None posted |
| Mar 12, 1985 | Supplement 53Manufacturing | Approved | None posted |
| Jan 25, 1984 | Supplement 52Manufacturing | Approved | None posted |
| Oct 25, 1983 | Supplement 50Manufacturing | Approved | None posted |
| Jul 27, 1983 | Supplement 49Manufacturing | Approved | None posted |
| Jul 27, 1983 | Supplement 47Manufacturing | Approved | None posted |
| Mar 31, 1983 | Supplement 46Manufacturing | Approved | None posted |
| Mar 21, 1983 | Supplement 45Manufacturing | Approved | None posted |
| Jun 23, 1982 | Supplement 44Manufacturing | Approved | None posted |
| Jun 23, 1982 | Supplement 42Manufacturing | Approved | None posted |
| Jan 28, 1982 | Supplement 40Manufacturing | Approved | None posted |
| Jan 28, 1982 | Supplement 38Manufacturing | Approved | None posted |
| Nov 29, 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
