NDA 14715, held by New River. Amitriptyline Hydrochloride; Perphenazine.
As of Nov 13, 2026, NDA 14715 (Triavil 2-25, Triavil 4-10, Triavil 2-10), held by New River, was first approved by FDA on Aug 23, 1965, with 48 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 1965 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Triavil 2-2525MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride; Perphenazine | Discontinued |
| Triavil 4-1010MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride; Perphenazine | Discontinued |
| Triavil 2-1010MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride; Perphenazine | Discontinued |
| Triavil 4-2525MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride; Perphenazine | Discontinued |
| Triavil 4-5050MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Amitriptyline Hydrochloride; Perphenazine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2009 | Supplement 80Labeling · Standard review | Approved | None posted |
| Mar 13, 2009 | Supplement 76Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 72Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 71Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 69Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 58Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 56Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 26Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 29Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 31Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 33Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 35Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 42Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 43Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 53Labeling | Approved | None posted |
| Dec 28, 1994 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Jul 7, 1994 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1989 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1989 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1988 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1988 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1986 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Dec 5, 1985 | Supplement 68Labeling | Approved | None posted |
| Aug 6, 1985 | Supplement 67Labeling | Approved | None posted |
| Aug 6, 1985 | Supplement 66Labeling | Approved | None posted |
| Aug 6, 1985 | Supplement 65Labeling | Approved | None posted |
| Sep 13, 1984 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| May 21, 1984 | Supplement 57Labeling | Approved | None posted |
| May 14, 1984 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1984 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| May 20, 1983 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1983 | Supplement 60Labeling | Approved | None posted |
| Jun 25, 1981 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1981 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Mar 3, 1981 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1980 | Supplement 52Labeling | Approved | None posted |
| Jun 23, 1980 | Supplement 51Labeling | Approved | None posted |
| Feb 11, 1980 | Supplement 47Labeling | Approved | None posted |
| Jan 29, 1980 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Mar 15, 1978 | Supplement 38Labeling | Approved | None posted |
| Oct 18, 1977 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1977 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jan 20, 1976 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1965 | Original applicationNew combination · Standard 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
