NDA 18615, held by Pharm Assoc. Sulfamethoxazole; Trimethoprim.
As of Nov 15, 2026, NDA 18615 (Sulfatrim Pediatric, Sulfatrim), held by Pharm Assoc, was first approved by FDA on Jan 7, 1983, with 43 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 1983 | Original application | Approved | None posted |
| Sulfatrim Pediatric200MG/5ML;40MG/5ML · suspension;oral | Sulfamethoxazole; Trimethoprim | Rx |
| Sulfatrim200MG/5ML;40MG/5ML · suspension;oral | Sulfamethoxazole; Trimethoprim | Discontinued |
| Feb 21, 2025 | Supplement 86Labeling · Standard review | Approved | |
| Jun 24, 2024 | Supplement 83Labeling · Standard review | Approved | |
| Oct 15, 2021 | Supplement 80Labeling · Standard review | Approved | |
| Sep 7, 2016 | Supplement 76Manufacturing | Approved | None posted |
| Sep 25, 2003 | Supplement 56Labeling | Approved | None posted |
| Feb 7, 2001 | Supplement 53Manufacturing | Approved | None posted |
| Nov 13, 2000 | Supplement 52Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 51Labeling | Approved | None posted |
| Jun 20, 1997 | Supplement 48Manufacturing | Approved | None posted |
| Feb 28, 1997 | Supplement 47Manufacturing | Approved | None posted |
| Jan 7, 1997 | Supplement 50Labeling | Approved | None posted |
| Jan 7, 1997 | Supplement 46Labeling | Approved | None posted |
| Jan 7, 1997 | Supplement 44Manufacturing | Approved | None posted |
| Jan 7, 1997 | Supplement 43Manufacturing | Approved | None posted |
| Jan 7, 1997 | Supplement 41Manufacturing | Approved | None posted |
| Jan 7, 1997 | Supplement 40Manufacturing | Approved | None posted |
| Nov 8, 1995 | Supplement 39Manufacturing | Approved | None posted |
| Dec 19, 1994 | Supplement 38Labeling | Approved | None posted |
| Feb 16, 1994 | Supplement 37Labeling | Approved | None posted |
| Nov 3, 1993 | Supplement 36Manufacturing | Approved | None posted |
| Nov 3, 1993 | Supplement 35Manufacturing | Approved | None posted |
| Nov 3, 1993 | Supplement 34Manufacturing | Approved | None posted |
| Nov 3, 1993 | Supplement 33Manufacturing | Approved | None posted |
| Mar 5, 1993 | Supplement 32Bioequivalence | Approved | None posted |
| Jan 22, 1993 | Supplement 29Manufacturing | Approved | None posted |
| Jul 24, 1991 | Supplement 30Manufacturing | Approved | None posted |
| Feb 26, 1991 | Supplement 22Manufacturing | Approved | None posted |
| Feb 26, 1991 | Supplement 21Manufacturing | Approved | None posted |
| Sep 28, 1990 | Supplement 31Manufacturing | Approved | None posted |
| May 8, 1990 | Supplement 28Labeling | Approved | None posted |
| Jan 12, 1990 | Supplement 26Labeling | Approved | None posted |
| Dec 15, 1988 | Supplement 25Manufacturing | Approved | None posted |
| Dec 15, 1988 | Supplement 24Manufacturing | Approved | None posted |
| Nov 1, 1988 | Supplement 20Labeling | Approved | None posted |
| Sep 8, 1988 | Supplement 18Manufacturing | Approved | None posted |
| Jul 14, 1988 | Supplement 19Manufacturing | Approved | None posted |
| Nov 27, 1987 | Supplement 13Manufacturing | Approved | None posted |
| Apr 22, 1987 | Supplement 12Manufacturing | Approved | None posted |
| Apr 22, 1987 | Supplement 11Manufacturing | Approved | None posted |
| Feb 13, 1986 | Supplement 9Manufacturing | Approved | None posted |
| Feb 13, 1986 | Supplement 8Manufacturing | Approved | None posted |
| Feb 13, 1986 | Supplement 7Manufacturing | Approved | None posted |
| Feb 13, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Jan 7, 1983 | 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
