The FDA’s NDA 017952 record shows two oral tablet products under the brand name Trimpex. Both contain trimethoprim—one at 100 mg (Trimpex) and the other at 200 mg (Trimpex 200)—and both are listed with a marketing status of Discontinued.
The record also includes multiple standard‑priority submissions, primarily for manufacturing (CMC) and labeling. All submissions carry the status “AP” (approved). The earliest approved filing is an original Type 5 new formulation or new manufacturer submission (submission 1) dated 30 May 1980. Subsequent manufacturing CMC submissions were approved on dates ranging from 28 Oct 1980 to 31 Jul 1997. A labeling submission (submission 5) received approval on 11 Jul 1983. Additional manufacturing submissions (numbers 3, 4, 6, 7, 8, 9, 12, 14) were also approved between 1981 and 1997.
Regulatorische Updates19. Sept. 2026•3 Min. Lesezeit
FDA Approves Manufacturing Submissions for Discontinued Trimpex Trimethoprim Tablets
The FDA’s NDA 017952 record lists two discontinued oral Trimpex tablets (100 mg and 200 mg trimethoprim) and documents a series of approved manufacturing and labeling submissions spanning 1980‑1997.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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