NDA 17377, held by Sun Pharm Industries. Sulfamethoxazole; Trimethoprim.
As of Nov 13, 2026, NDA 17377 (Bactrim, Bactrim Ds), held by Sun Pharm Industries, was first approved by FDA on Jul 30, 1973, with 61 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (sulfamethoxazole and trimethoprim) tablets 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 |
|---|---|---|---|
| Jun 15, 1990 | Supplement 40Efficacy (new indication or use) | Approved | None posted |
| Feb 23, 1982 | Supplement 32Efficacy (new indication or use) | Approved | None posted |
| Jul 30, 1973 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bactrim400MG;80MG · tablet;oral | Sulfamethoxazole; Trimethoprim | DiscontinuedReference drug |
| Bactrim Ds800MG;160MG · tablet;oral | Sulfamethoxazole; Trimethoprim | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2025 | Supplement 85Labeling · Standard review | Approved | |
| Jun 24, 2024 | Supplement 84Labeling · Standard review | Approved | |
| Apr 30, 2021 | Supplement 83Labeling · Standard review | Approved | |
| Jul 28, 2020 | Supplement 80Labeling · Standard review | Approved | |
| Apr 18, 2016 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Nov 27, 2015 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Apr 13, 2015 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Apr 7, 2015 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Jul 16, 2014 | Supplement 74Labeling · Standard review | Approved | |
| Jul 12, 2013 | Supplement 68Labeling | Approved | |
| Jul 12, 2013 | Supplement 73Labeling · Standard review | Approved | |
| Aug 29, 2012 | Supplement 71Labeling · Standard review | Approved | |
| Jul 27, 2010 | Supplement 67Labeling | Approved | |
| Jun 28, 2010 | Supplement 66Labeling · Standard review | Approved | |
| Jun 5, 2007 | Supplement 63Labeling · Standard review | Approved | |
| Feb 12, 2003 | Supplement 57Labeling · Standard review | Approved | |
| Oct 17, 2002 | Supplement 58Manufacturing · Standard review | Approved | |
| Jul 3, 2000 | Supplement 50Labeling | Approved | None posted |
| Jul 3, 2000 | Supplement 53Labeling | Approved | None posted |
| Nov 17, 1998 | Supplement 56Labeling · Standard review | Approved | None posted |
| Mar 6, 1996 | Supplement 47Labeling | Approved | None posted |
| Apr 18, 1994 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1990 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jun 15, 1990 | Supplement 40Efficacy (new indication or use) | Approved | None posted |
| Aug 11, 1987 | Supplement 46Labeling | Approved | None posted |
| May 11, 1987 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| May 11, 1987 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Mar 19, 1985 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Nov 23, 1984 | Supplement 43Labeling | Approved | None posted |
| Jun 12, 1984 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 9, 1984 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Aug 1, 1983 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jun 15, 1983 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Feb 23, 1982 | Supplement 32Efficacy (new indication or use) | Approved | None posted |
| Dec 9, 1981 | Supplement 36Labeling | Approved | None posted |
| Oct 9, 1981 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1981 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Apr 1, 1981 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1980 | Supplement 33Labeling | Approved | None posted |
| Mar 6, 1980 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 17, 1979 | Supplement 30Labeling | Approved | None posted |
| Jul 26, 1979 | Supplement 23Labeling | Approved | None posted |
| Apr 18, 1979 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 11, 1978 | Supplement 27Labeling | Approved | None posted |
| Apr 19, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1978 | Supplement 26Labeling | Approved | None posted |
| Mar 1, 1978 | Supplement 25Labeling | Approved | None posted |
| Jan 12, 1978 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 2, 1977 | Supplement 22Labeling | Approved | None posted |
| Feb 15, 1977 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1977 | Supplement 21Labeling | Approved | None posted |
| Nov 22, 1976 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 1, 1976 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 12, 1976 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1976 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1975 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 14, 1975 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1975 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 5, 1974 | Supplement 9Labeling | Approved | None posted |
| Dec 5, 1974 | Supplement 10Labeling | Approved | None posted |
| Jun 12, 1974 | Supplement 4 | Approved | None posted |
| Jul 30, 1973 | 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
