NDA 17105, held by Ajenat Pharms. Clorazepate Dipotassium.
As of Nov 13, 2026, NDA 17105 (Tranxene, Tranxene Sd), held by Ajenat Pharms, was first approved by FDA on Jun 23, 1972, with 52 approved supplements and 0 published complete response letters.
| Jan 29, 1981 | Supplement 39Efficacy (new indication or use) | Approved | None posted |
| Jun 23, 1972 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Tranxene3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Tranxene7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Tranxene15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Tranxene Sd22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Tranxene Sd11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Tranxene3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Tranxene7.5MG · tablet;oral | Clorazepate Dipotassium | RxReference drug |
| Tranxene15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clorazepate Dipotassium | DiscontinuedReference drug |
| Jan 13, 2023 | Supplement 85Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 84Labeling | Approved | |
| Dec 16, 2016 | Supplement 79Labeling | Approved | |
| Feb 3, 2015 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Jul 19, 2011 | Supplement 77REMS | Approved | |
| Jun 7, 2010 | Supplement 76Labeling · Standard review | Approved | |
| Apr 23, 2009 | Supplement 75Labeling | Approved | |
| Mar 13, 2003 | Supplement 70Labeling · Standard review | Approved | |
| Aug 28, 2002 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Feb 7, 2002 | Supplement 62Labeling | Approved | |
| Feb 7, 2002 | Supplement 59Labeling | Approved | |
| Aug 4, 1999 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| May 8, 1998 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1996 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Nov 8, 1988 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1987 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1987 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1987 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Nov 14, 1986 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1986 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1986 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1985 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1984 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jan 29, 1981 | Supplement 39Efficacy (new indication or use) | Approved | None posted |
| Oct 28, 1980 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Jul 14, 1980 | Supplement 43Labeling | Approved | None posted |
| Mar 10, 1980 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Dec 12, 1979 | Supplement 40Labeling | Approved | None posted |
| Jul 9, 1979 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1979 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1979 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jun 5, 1979 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| May 31, 1979 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Dec 6, 1978 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| May 5, 1978 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Apr 17, 1978 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 21, 1977 | Supplement 30Labeling | Approved | None posted |
| Oct 20, 1977 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1977 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 4, 1977 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1976 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1976 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1976 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1976 | Supplement 16Labeling | Approved | None posted |
| Jul 30, 1976 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 7, 1976 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1975 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1975 | Supplement 13Labeling | Approved | None posted |
| Sep 10, 1975 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1975 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 23, 1972 | Original applicationNew molecular entity · 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
