NDA 16016, held by Merck. Chlorothiazide; Methyldopa.
As of Nov 13, 2026, NDA 16016 (Aldoclor-150, Aldoclor-250), held by Merck, was first approved by FDA on Mar 20, 1968, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 1968 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aldoclor-150150MG;250MG · tablet;oral | Chlorothiazide; Methyldopa | Discontinued |
| Aldoclor-250250MG;250MG · tablet;oral | Chlorothiazide; Methyldopa | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 1999 | Supplement 70Labeling · Standard review | Approved | None posted |
| Aug 5, 1997 | Supplement 69Labeling · Standard review | Approved | None posted |
| May 23, 1997 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1994 | Supplement 66Labeling · Standard review | Approved | None posted |
| Sep 26, 1994 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1994 | Supplement 65Labeling · Standard review | Approved | None posted |
| Sep 17, 1992 | Supplement 64Labeling · Standard review | Approved | None posted |
| Sep 3, 1992 | Supplement 61Labeling · Standard review | Approved | None posted |
| Sep 13, 1990 | Supplement 63Labeling · Standard review | Approved | None posted |
| Sep 6, 1988 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1988 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1988 | Supplement 60Labeling · Standard review | Approved | None posted |
| Aug 26, 1987 | Supplement 59Labeling · Standard review | Approved | None posted |
| May 8, 1987 | Supplement 51Labeling · Standard review | Approved | None posted |
| Jun 2, 1986 | Supplement 57Labeling · Standard review | Approved | None posted |
| Jan 14, 1986 | Supplement 56Labeling · Standard review | Approved | None posted |
| Sep 24, 1984 | Supplement 55Labeling · Standard review | Approved | None posted |
| Apr 3, 1984 | Supplement 54Labeling · Standard review | Approved | None posted |
| Dec 23, 1983 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1982 | Supplement 52Labeling · Standard review | Approved | None posted |
| Sep 23, 1981 | Supplement 50Labeling · Standard review | Approved | None posted |
| Jun 17, 1981 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1981 | Supplement 48Labeling · Standard review | Approved | None posted |
| Apr 9, 1981 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1981 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jan 23, 1981 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1981 | Supplement 45Labeling · Standard review | Approved | None posted |
| Nov 14, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 42Labeling · Standard review | Approved | None posted |
| Sep 18, 1979 | Supplement 40Labeling · Standard review | Approved | None posted |
| Jul 3, 1979 | Supplement 41Labeling · Standard review | Approved | None posted |
| Jun 18, 1979 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1979 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Mar 9, 1979 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1978 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Sep 12, 1978 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 12, 1978 | Supplement 32Labeling · Standard review | Approved | None posted |
| Aug 29, 1978 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1978 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1976 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1976 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jun 6, 1975 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 20, 1968 | Original applicationNew combination · 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
