NDA 17598, held by Monarch Pharms. Sulfamethoxazole; Trimethoprim.
As of Nov 13, 2026, NDA 17598 (Septra, Septra Grape), held by Monarch Pharms, was first approved by FDA on May 31, 1975, with 38 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 1990 | Supplement 28Efficacy (new indication or use) | Approved | None posted |
| Oct 11, 1978 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Mar 1, 1978 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| May 31, 1975 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Septra200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · suspension;oral | Sulfamethoxazole; Trimethoprim | Discontinued |
| Septra Grape200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · suspension;oral | Sulfamethoxazole; Trimethoprim | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2009 | Supplement 9Labeling | Approved | None posted |
| Mar 11, 2008 | Supplement 40Labeling · Standard review | Approved | |
| Sep 10, 2007 | Supplement 41Labeling · Standard review | Approved | |
| Jul 28, 2005 | Supplement 39Labeling · Standard review | Approved | |
| Feb 17, 2000 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Mar 19, 1997 | Supplement 36Labeling · Standard review | Approved | None posted |
| Mar 19, 1997 | Supplement 26Labeling | Approved | None posted |
| Mar 19, 1997 | Supplement 23Labeling | Approved | None posted |
| Feb 13, 1997 | Supplement 37Labeling · Standard review | Approved | None posted |
| Sep 11, 1996 | Supplement 33Labeling · Standard review | Approved | None posted |
| Jan 7, 1994 | Supplement 32Labeling · Standard review | Approved | None posted |
| Feb 22, 1993 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1992 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1991 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1991 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1990 | Supplement 21Labeling | Approved | None posted |
| Jun 15, 1990 | Supplement 28Efficacy (new indication or use) | Approved | None posted |
| Sep 9, 1988 | Supplement 22Labeling | Approved | None posted |
| Aug 8, 1988 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 11, 1987 | Supplement 19Labeling | Approved | None posted |
| Feb 12, 1986 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1984 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1984 | Supplement 17Labeling | Approved | None posted |
| Apr 27, 1982 | Supplement 16Labeling | Approved | None posted |
| Mar 22, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1981 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 13, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1980 | Supplement 12Labeling | Approved | None posted |
| Dec 18, 1979 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1979 | Supplement 10Labeling | Approved | None posted |
| Oct 11, 1978 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Mar 1, 1978 | Supplement 5Efficacy (new indication or use) | Approved | None posted |
| Aug 26, 1977 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1976 | Supplement 4Labeling | Approved | None posted |
| Nov 12, 1976 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1976 | Supplement 3Labeling | Approved | None posted |
| Sep 17, 1975 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1975 | Supplement 1Labeling | Approved | None posted |
| May 31, 1975 | Original applicationNew formulation or manufacturer · 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
