NDA 13400, held by Merck. Methyldopa.
As of Nov 13, 2026, NDA 13400 (Aldomet), held by Merck, was first approved by FDA on Dec 20, 1962, with 57 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 1962 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Aldomet250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methyldopa | DiscontinuedReference drug |
| Aldomet500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methyldopa | DiscontinuedReference drug |
| Aldomet125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Methyldopa | DiscontinuedReference drug |
| Sep 17, 2004 | Supplement 86Labeling · Priority review | Approved | |
| Nov 10, 1998 | Supplement 85Labeling · Priority review | Approved | None posted |
| Aug 5, 1997 | Supplement 81Labeling · Priority review | Approved | None posted |
| Aug 5, 1997 | Supplement 84Labeling · Priority review | Approved | None posted |
| Jul 7, 1997 | Supplement 82Manufacturing · Priority review | Approved | None posted |
| Jul 7, 1997 | Supplement 83Manufacturing · Priority review | Approved | None posted |
| Nov 30, 1995 | Supplement 80Manufacturing · Priority review | Approved | None posted |
| Dec 16, 1994 | Supplement 78Labeling · Priority review | Approved | None posted |
| Sep 26, 1994 | Supplement 79Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1992 | Supplement 77Labeling · Priority review | Approved | None posted |
| Sep 13, 1990 | Supplement 76Labeling · Priority review | Approved | None posted |
| Nov 22, 1988 | Supplement 75Labeling · Priority review | Approved | None posted |
| Apr 26, 1988 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| May 11, 1987 | Supplement 61Labeling · Priority review | Approved | None posted |
| May 11, 1987 | Supplement 73Labeling · Priority review | Approved | None posted |
| Oct 22, 1985 | Supplement 72Labeling · Priority review | Approved | None posted |
| Feb 22, 1985 | Supplement 71Labeling · Priority review | Approved | None posted |
| Jan 17, 1985 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1984 | Supplement 69Labeling · Priority review | Approved | None posted |
| Apr 10, 1984 | Supplement 68Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1984 | Supplement 67Labeling · Priority review | Approved | None posted |
| Dec 23, 1983 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1983 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1982 | Supplement 63Labeling · Priority review | Approved | None posted |
| Apr 19, 1982 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Apr 7, 1982 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Apr 7, 1982 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Nov 17, 1981 | Supplement 56Labeling · Priority review | Approved | None posted |
| Oct 14, 1981 | Supplement 60Labeling · Priority review | Approved | None posted |
| Aug 28, 1981 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Aug 28, 1981 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Jun 17, 1981 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Apr 9, 1981 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Jan 23, 1981 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Nov 14, 1980 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Oct 10, 1979 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Jul 25, 1979 | Supplement 42Labeling · Priority review | Approved | None posted |
| Jul 25, 1979 | Supplement 48Labeling · Priority review | Approved | None posted |
| Mar 9, 1979 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Nov 7, 1978 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1978 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1978 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Aug 24, 1978 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1978 | Supplement 41Labeling · Priority review | Approved | None posted |
| Feb 15, 1978 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Oct 21, 1977 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| May 6, 1977 | Supplement 38Labeling · Priority review | Approved | None posted |
| May 6, 1977 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| May 2, 1977 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Feb 7, 1977 | Supplement 35Labeling · Priority review | Approved | None posted |
| Nov 9, 1976 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Nov 9, 1976 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Aug 31, 1976 | Supplement 33Labeling · Priority review | Approved | None posted |
| Jul 22, 1976 | Supplement 31Labeling · Priority review | Approved | None posted |
| Jan 6, 1976 | Supplement 29Labeling · Priority review | Approved | None posted |
| Dec 12, 1975 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Jun 6, 1975 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Dec 20, 1962 | 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
