NDA 18343, held by Aarxion Anda Hlding. Captopril.
As of Nov 13, 2026, NDA 18343 (Capoten), held by Aarxion Anda Hlding, was first approved by FDA on Apr 6, 1981, with 77 approved supplements and 0 published complete response letters.
| Jan 28, 1994 | Supplement 64Efficacy (new indication or use) · Priority review | Approved | None posted |
| Sep 23, 1993 | Supplement 48Efficacy (new indication or use) | Approved | None posted |
| May 13, 1988 | Supplement 40Efficacy (new indication or use) | Approved | None posted |
| Jan 17, 1985 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Aug 28, 1984 | Supplement 14Efficacy (new indication or use) | Approved | None posted |
| Oct 25, 1982 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| Apr 6, 1981 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Capoten50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Capoten25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Capoten100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Capoten150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Capoten12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Capoten37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Capoten75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Captopril | DiscontinuedReference drug |
| Aug 1, 2017 | Supplement 87Labeling · Standard review | Approved | |
| Jun 19, 2015 | Supplement 86Labeling · Standard review | Approved | |
| Dec 24, 2014 | Supplement 85Labeling · Standard review | Approved | |
| Aug 27, 2012 | Supplement 84Labeling | Approved | |
| Dec 14, 2011 | Supplement 83Labeling | Approved | |
| May 19, 2011 | Supplement 82Labeling | Approved | |
| Sep 25, 2008 | Supplement 81Labeling · Standard review | Approved | |
| May 7, 2004 | Supplement 75Labeling · Standard review | Approved | |
| Apr 20, 1999 | Supplement 73Labeling · Standard review | Approved | None posted |
| Jan 9, 1998 | Supplement 72Manufacturing · Priority review | Approved | None posted |
| Aug 21, 1997 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Jul 31, 1996 | Supplement 68Labeling · Standard review | Approved | None posted |
| Jun 25, 1996 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1996 | Supplement 69Manufacturing · Priority review | Approved | None posted |
| Jun 19, 1995 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Jun 13, 1995 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Mar 6, 1995 | Supplement 67Manufacturing · Priority review | Approved | None posted |
| Mar 31, 1994 | Supplement 63Labeling · Standard review | Approved | None posted |
| Jan 28, 1994 | Supplement 64Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 4, 1993 | Supplement 65Labeling · Standard review | Approved | None posted |
| Sep 23, 1993 | Supplement 48Efficacy (new indication or use) | Approved | None posted |
| May 12, 1993 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Dec 21, 1992 | Supplement 59Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1992 | Supplement 60Labeling | Approved | None posted |
| Jun 25, 1992 | Supplement 61Labeling | Approved | None posted |
| May 7, 1992 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Jan 14, 1992 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Oct 7, 1991 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Apr 12, 1991 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Mar 21, 1991 | Supplement 51Labeling | Approved | None posted |
| Jan 31, 1991 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Nov 5, 1990 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Sep 27, 1990 | Supplement 50Labeling | Approved | None posted |
| May 10, 1990 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Mar 23, 1990 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Oct 19, 1989 | Supplement 46Labeling | Approved | None posted |
| May 3, 1989 | Supplement 47Labeling | Approved | None posted |
| May 13, 1988 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| May 13, 1988 | Supplement 40Efficacy (new indication or use) | Approved | None posted |
| Feb 19, 1988 | Supplement 44Labeling | Approved | None posted |
| Jun 26, 1987 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Apr 2, 1987 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Feb 13, 1987 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Jan 21, 1987 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Jan 6, 1987 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1986 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Aug 14, 1986 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Jul 24, 1986 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| May 27, 1986 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Mar 4, 1986 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Feb 27, 1986 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jan 17, 1986 | Supplement 27Labeling | Approved | None posted |
| Dec 18, 1985 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Jul 10, 1985 | Supplement 9Labeling | Approved | None posted |
| Jun 12, 1985 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Apr 16, 1985 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Apr 16, 1985 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jan 17, 1985 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Nov 19, 1984 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Oct 12, 1984 | Supplement 21Labeling | Approved | None posted |
| Sep 18, 1984 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 28, 1984 | Supplement 14Efficacy (new indication or use) | Approved | None posted |
| Jul 12, 1984 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1984 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1984 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Feb 7, 1984 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Feb 7, 1984 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Oct 14, 1983 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Oct 14, 1983 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| May 18, 1983 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Oct 25, 1982 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| Oct 7, 1982 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 9, 1982 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Feb 25, 1982 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 30, 1981 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Oct 27, 1981 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jun 12, 1981 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1981 | 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
