ANDA 216393, held by Novitium Pharma. Trimethoprim.
As of Nov 14, 2026, ANDA 216393 (Trimethoprim), held by Novitium Pharma, was first approved by FDA on Oct 28, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets and other antibacterial drugs, 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 the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trimethoprim100MG · tablet;oral | Trimethoprim | Rx |
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
