NDA 12703, held by Astrazeneca. Amitriptyline Hydrochloride.
As of Nov 13, 2026, NDA 12703 (Elavil), held by Astrazeneca, was first approved by FDA on Apr 7, 1961, with 52 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 1961 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Elavil10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |
| Elavil25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |
| Elavil50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |
| Elavil75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |
| Elavil100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |
| Elavil150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride | DiscontinuedReference drug |
| Jul 29, 2003 | Supplement 93Labeling · Priority review | Approved | |
| Mar 27, 2001 | Supplement 92Labeling · Priority review | Approved | |
| Jan 22, 2001 | Supplement 91Manufacturing · Priority review | Approved | None posted |
| Apr 5, 2000 | Supplement 90Labeling · Priority review | Approved | None posted |
| Apr 5, 2000 | Supplement 88Labeling · Priority review | Approved | None posted |
| Apr 5, 2000 | Supplement 86Labeling · Priority review | Approved | None posted |
| Apr 5, 2000 | Supplement 84Labeling · Priority review | Approved | None posted |
| Dec 24, 1998 | Supplement 89Manufacturing · Priority review | Approved | None posted |
| Dec 30, 1996 | Supplement 87Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1995 | Supplement 85Manufacturing · Priority review | Approved | None posted |
| Jun 1, 1994 | Supplement 83Manufacturing · Priority review | Approved | None posted |
| Jun 1, 1994 | Supplement 82Manufacturing · Priority review | Approved | None posted |
| Jun 24, 1991 | Supplement 81Labeling · Priority review | Approved | None posted |
| Jun 24, 1991 | Supplement 79Labeling · Priority review | Approved | None posted |
| Jun 24, 1991 | Supplement 76Labeling · Priority review | Approved | None posted |
| Jul 28, 1989 | Supplement 80Manufacturing · Priority review | Approved | None posted |
| Dec 12, 1988 | Supplement 77Manufacturing · Priority review | Approved | None posted |
| Apr 8, 1988 | Supplement 78Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1988 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Jul 10, 1986 | Supplement 73Labeling · Priority review | Approved | None posted |
| Apr 2, 1986 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Sep 20, 1985 | Supplement 72Labeling · Priority review | Approved | None posted |
| Sep 13, 1984 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Aug 15, 1984 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| May 21, 1984 | Supplement 65Labeling · Priority review | Approved | None posted |
| Mar 7, 1984 | Supplement 69Manufacturing · Priority review | Approved | None posted |
| May 26, 1983 | Supplement 67Manufacturing · Priority review | Approved | None posted |
| May 3, 1983 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Mar 15, 1983 | Supplement 68Labeling · Priority review | Approved | None posted |
| Sep 4, 1981 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Jun 25, 1981 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Mar 23, 1981 | Supplement 61Labeling · Priority review | Approved | None posted |
| Mar 9, 1981 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Mar 2, 1981 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Mar 2, 1981 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Mar 2, 1981 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1980 | Supplement 60Labeling · Priority review | Approved | None posted |
| Jun 23, 1980 | Supplement 59Labeling · Priority review | Approved | None posted |
| Mar 4, 1980 | Supplement 54Labeling · Priority review | Approved | None posted |
| Jan 29, 1980 | Supplement 53Labeling · Priority review | Approved | None posted |
| Jan 29, 1980 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Nov 6, 1979 | Supplement 52Labeling · Priority review | Approved | None posted |
| Jan 25, 1978 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1977 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Oct 28, 1976 | Supplement 39Labeling · Priority review | Approved | None posted |
| Sep 17, 1976 | Supplement 42Labeling · Priority review | Approved | None posted |
| Aug 2, 1976 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Aug 2, 1976 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Sep 18, 1975 | Supplement 38Labeling · Priority review | Approved | None posted |
| Sep 18, 1975 | Supplement 37Labeling · Priority review | Approved | None posted |
| Sep 17, 1975 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1975 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Apr 7, 1961 | Original applicationNew molecular entity · Priority review | 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
