NDA 17376, held by Monarch Pharms. Sulfamethoxazole; Trimethoprim.
As of Nov 13, 2026, NDA 17376 (Septra, Septra Ds), held by Monarch Pharms, was first approved by FDA on Jul 30, 1973, with 55 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 1990 | Supplement 41Efficacy (new indication or use) | Approved | None posted |
| Jul 26, 1979 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Oct 11, 1978 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Jul 30, 1973 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Septra400MG;80MG · tablet;oral | Sulfamethoxazole; Trimethoprim | Discontinued |
| Septra Ds800MG;160MG · tablet;oral | Sulfamethoxazole; Trimethoprim | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2025 | Supplement 68Labeling · Standard review | Approved | |
| Jun 24, 2024 | Supplement 66Labeling · Standard review | Approved | |
| Nov 18, 2020 | Supplement 62Labeling · Standard review | Approved | |
| Aug 10, 2020 | Supplement 63Labeling · Standard review | Approved | |
| Aug 10, 2020 | Supplement 64Labeling · Standard review | Approved | |
| Jul 15, 2020 | Supplement 65Labeling · Standard review | Approved | |
| Feb 1, 2018 | Supplement 61Labeling · Standard review | Approved | |
| Aug 30, 2013 | Supplement 60Labeling · Standard review | Approved | |
| Mar 11, 2008 | Supplement 58Labeling · Standard review | Approved | |
| Sep 10, 2007 | Supplement 59Labeling · Standard review | Approved | |
| Jul 28, 2005 | Supplement 56Labeling · Standard review | Approved | |
| Oct 4, 2000 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Jan 31, 2000 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Apr 7, 1998 | Supplement 52Labeling · Standard review | Approved | None posted |
| Mar 19, 1997 | Supplement 42Labeling | Approved | None posted |
| Mar 19, 1997 | Supplement 44Labeling | Approved | None posted |
| Mar 19, 1997 | Supplement 51Labeling · Standard review | Approved | None posted |
| Feb 12, 1997 | Supplement 53Labeling · Standard review | Approved | None posted |
| Sep 11, 1996 | Supplement 48Labeling · Standard review | Approved | None posted |
| Jan 7, 1994 | Supplement 47Labeling · Standard review | Approved | None posted |
| Feb 22, 1993 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Dec 1, 1992 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Nov 9, 1990 | Supplement 39Labeling | Approved | None posted |
| Jun 15, 1990 | Supplement 41Efficacy (new indication or use) | Approved | None posted |
| Feb 2, 1989 | Supplement 40Labeling | Approved | None posted |
| Aug 11, 1987 | Supplement 37Labeling | Approved | None posted |
| Aug 9, 1985 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Feb 20, 1985 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Jan 16, 1985 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Nov 1, 1984 | Supplement 31Labeling | Approved | None posted |
| Mar 25, 1983 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Dec 7, 1982 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Apr 27, 1982 | Supplement 30Labeling | Approved | None posted |
| Nov 3, 1981 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Oct 9, 1981 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jan 9, 1981 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Oct 31, 1980 | Supplement 26Labeling | Approved | None posted |
| Oct 28, 1980 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Sep 9, 1980 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jul 26, 1979 | Supplement 21Efficacy (new indication or use) | Approved | None posted |
| Dec 8, 1978 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1978 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Oct 11, 1978 | Supplement 17Efficacy (new indication or use) | Approved | None posted |
| Jul 5, 1977 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Apr 21, 1977 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Mar 7, 1977 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Dec 27, 1976 | Supplement 12Labeling | Approved | None posted |
| Nov 22, 1976 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Nov 22, 1976 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Feb 12, 1976 | Supplement 10Labeling | Approved | None posted |
| May 15, 1975 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 25, 1974 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Oct 8, 1974 | Supplement 2 | Approved | None posted |
| Oct 8, 1974 | Supplement 5Labeling | Approved | None posted |
| May 1, 1974 | Supplement 3 | Approved | None posted |
| Jul 30, 1973 | Original applicationNew molecular entity, new combination · Priority review | Approved |
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
