ANDA 71259, held by Teva. Trimethoprim.
As of Nov 14, 2026, ANDA 71259 (Trimethoprim), held by Teva, was first approved by FDA on Jun 18, 1987, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trimethoprim200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท tablet;oral | Trimethoprim | Discontinued |
| Mar 27, 2012 | Supplement 27Labeling | Approved | |
| May 15, 2002 | Supplement 18Labeling | Approved | None posted |
| May 15, 2002 | Supplement 17Manufacturing | Approved | None posted |
| May 15, 2002 | Supplement 16Manufacturing | Approved | None posted |
| May 15, 2002 | Supplement 15Manufacturing | Approved | None posted |
| May 15, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 13Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Apr 16, 1997 | Supplement 10Manufacturing | Approved | None posted |
| Mar 6, 1997 | Supplement 11Labeling | Approved | None posted |
| Sep 5, 1996 | Supplement 9Manufacturing | Approved | None posted |
| Jul 17, 1995 | Supplement 5Manufacturing | Approved | None posted |
| Oct 17, 1994 | Supplement 4Manufacturing | Approved | None posted |
| Mar 1, 1993 | Supplement 3Manufacturing | Approved | None posted |
| Feb 10, 1988 | Supplement 2Manufacturing | Approved | None posted |
| Oct 28, 1987 | Supplement 1Manufacturing | Approved | None posted |
| Jun 18, 1987 | 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
