NDA 17090, held by Specgx LLC. Imipramine Pamoate.
As of Nov 14, 2026, NDA 17090 (Tofranil-Pm), held by Specgx LLC, was first approved by FDA on Mar 11, 1973, with 56 approved supplements and 0 published complete response letters.
| Aug 12, 1987 | Supplement 51Efficacy (new indication or use) | Approved | None posted |
| Mar 11, 1973 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Tofranil-PmEQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Imipramine Pamoate | DiscontinuedReference drug |
| Tofranil-PmEQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Imipramine Pamoate | DiscontinuedReference drug |
| Tofranil-PmEQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Imipramine Pamoate | DiscontinuedReference drug |
| Tofranil-PmEQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Imipramine Pamoate | DiscontinuedReference drug |
| Jul 28, 2014 | Supplement 78Labeling · Standard review | Approved | |
| Jul 10, 2014 | Supplement 77Labeling | Approved | |
| Oct 26, 2012 | Supplement 76Labeling · Standard review | Approved | |
| Jul 13, 2007 | Supplement 74Labeling · Standard review | Approved | |
| Jan 12, 2005 | Supplement 70Labeling · Standard review | Approved | |
| Mar 26, 2004 | Supplement 69Labeling · Standard review | Approved | |
| Jun 20, 2002 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Jan 3, 2002 | Supplement 67Labeling · Standard review | Approved | None posted |
| Jun 21, 2000 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Apr 26, 2000 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2000 | Supplement 60Labeling · Standard review | Approved | None posted |
| Mar 27, 2000 | Supplement 61Labeling · Standard review | Approved | None posted |
| Mar 27, 2000 | Supplement 62Labeling · Standard review | Approved | None posted |
| Apr 15, 1999 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1997 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1993 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1992 | Supplement 58Labeling | Approved | None posted |
| Aug 2, 1991 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Apr 5, 1990 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1989 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1989 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1989 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1989 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1987 | Supplement 51Efficacy (new indication or use) | Approved | None posted |
| Jul 18, 1986 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| May 20, 1986 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1985 | Supplement 49Labeling | Approved | None posted |
| May 5, 1985 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1985 | Supplement 47Labeling | Approved | None posted |
| Nov 5, 1984 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1984 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1984 | Supplement 45Labeling | Approved | None posted |
| May 4, 1983 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Feb 4, 1981 | Supplement 40Labeling | Approved | None posted |
| Apr 16, 1980 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1980 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1980 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1979 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1979 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1979 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 2, 1979 | Supplement 32Labeling | Approved | None posted |
| Jun 7, 1977 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1975 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1974 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 28, 1974 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 28, 1974 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 28, 1974 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| May 28, 1974 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| May 28, 1974 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 28, 1974 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| May 22, 1974 | Supplement 10REMS · Standard review | Approved | None posted |
| May 22, 1974 | Supplement 9REMS · Standard review | Approved | None posted |
| May 22, 1974 | Supplement 8REMS · Standard review | Approved | None posted |
| May 22, 1974 | Supplement 7REMS · Standard review | Approved | None posted |
| May 22, 1974 | Supplement 6REMS · Standard review | Approved | None posted |
| Mar 11, 1973 | Original applicationNew active ingredient · 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
