NDA 6035, held by Edison Theraps LLC. Methylergonovine Maleate.
As of Nov 13, 2026, NDA 6035 (Methergine), held by Edison Theraps LLC, was first approved by FDA on Nov 19, 1946, with 54 approved supplements and 0 published complete response letters.
| Jun 17, 1981 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Jul 22, 1980 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| May 15, 1979 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1979 | Supplement 19Efficacy (new indication or use) | Approved | None posted |
| Nov 19, 1946 | Original application | Approved | None posted |
| Methergine0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methylergonovine Maleate | DiscontinuedReference drug |
| Methergine0.2MG/ML · injectable;injection | Methylergonovine Maleate | DiscontinuedReference drug |
| May 29, 2025 | Supplement 80Labeling · Standard review | Approved | |
| May 21, 2013 | Supplement 79Manufacturing | Approved | None posted |
| Jun 25, 2012 | Supplement 78Labeling | Approved | |
| Apr 26, 2007 | Supplement 75Labeling · Standard review | Approved | |
| Feb 18, 2004 | Supplement 72Labeling · Standard review | Approved | |
| Oct 1, 2003 | Supplement 73Labeling · Standard review | Approved | |
| Feb 5, 2002 | Supplement 68Manufacturing | Approved | None posted |
| Feb 5, 2002 | Supplement 69Manufacturing | Approved | None posted |
| Jan 28, 2002 | Supplement 67Manufacturing | Approved | None posted |
| May 22, 2001 | Supplement 65Manufacturing | Approved | None posted |
| Apr 3, 2001 | Supplement 66Manufacturing | Approved | None posted |
| Apr 14, 2000 | Supplement 64Manufacturing | Approved | None posted |
| Dec 9, 1999 | Supplement 63Manufacturing | Approved | None posted |
| Apr 22, 1999 | Supplement 62Manufacturing | Approved | None posted |
| Jul 15, 1997 | Supplement 61Manufacturing | Approved | None posted |
| May 27, 1997 | Supplement 60Labeling · Standard review | Approved | None posted |
| Feb 22, 1996 | Supplement 58Labeling · Standard review | Approved | None posted |
| Feb 21, 1996 | Supplement 59Manufacturing | Approved | None posted |
| Oct 17, 1995 | Supplement 57Manufacturing | Approved | None posted |
| Sep 22, 1995 | Supplement 55Manufacturing | Approved | None posted |
| Sep 22, 1995 | Supplement 56Manufacturing | Approved | None posted |
| Mar 22, 1995 | Supplement 50Labeling | Approved | None posted |
| Jul 18, 1994 | Supplement 51Manufacturing | Approved | None posted |
| Jul 7, 1994 | Supplement 54Manufacturing | Approved | None posted |
| Apr 25, 1994 | Supplement 52Labeling · Standard review | Approved | None posted |
| Mar 11, 1993 | Supplement 53Manufacturing | Approved | None posted |
| May 28, 1991 | Supplement 49Labeling | Approved | None posted |
| Sep 6, 1990 | Supplement 48Manufacturing | Approved | None posted |
| Oct 20, 1989 | Supplement 43Manufacturing | Approved | None posted |
| Oct 20, 1989 | Supplement 44Manufacturing | Approved | None posted |
| Oct 20, 1989 | Supplement 46Manufacturing | Approved | None posted |
| Oct 20, 1989 | Supplement 47Manufacturing | Approved | None posted |
| Mar 2, 1989 | Supplement 42Manufacturing | Approved | None posted |
| Jul 6, 1987 | Supplement 36Manufacturing | Approved | None posted |
| May 6, 1987 | Supplement 37Labeling | Approved | None posted |
| Jan 7, 1986 | Supplement 34Labeling | Approved | None posted |
| Sep 30, 1985 | Supplement 31Labeling | Approved | None posted |
| Jun 18, 1985 | Supplement 32Manufacturing | Approved | None posted |
| May 14, 1985 | Supplement 33Manufacturing | Approved | None posted |
| Oct 22, 1984 | Supplement 29Manufacturing | Approved | None posted |
| Aug 30, 1984 | Supplement 30Manufacturing | Approved | None posted |
| Sep 28, 1981 | Supplement 23Manufacturing | Approved | None posted |
| Jun 17, 1981 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Jun 17, 1981 | Supplement 24Manufacturing | Approved | None posted |
| Jun 15, 1981 | Supplement 25Manufacturing | Approved | None posted |
| Jul 22, 1980 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| May 15, 1979 | Supplement 20Efficacy (new indication or use) | Approved | None posted |
| Jan 23, 1979 | Supplement 19Efficacy (new indication or use) | Approved | None posted |
| Jan 16, 1979 | Supplement 18Manufacturing | Approved | None posted |
| Jun 9, 1977 | Supplement 16Manufacturing | Approved | None posted |
| May 3, 1976 | Supplement 13Manufacturing | Approved | None posted |
| Jan 16, 1976 | Supplement 12Manufacturing | Approved | None posted |
| May 20, 1975 | Supplement 10Manufacturing | Approved | None posted |
| May 20, 1975 | Supplement 11Manufacturing | Approved | None posted |
| Nov 19, 1946 | Original application | 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
