ANDA 91437, held by Novel Labs Inc. Trimethoprim.
As of Nov 14, 2026, ANDA 91437 (Trimethoprim), held by Novel Labs Inc, was first approved by FDA on Jun 15, 2011, with 2 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, USP and other antibacterial drugs, trimethoprim tablets, USP 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 |
|---|---|---|---|
| Jun 15, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trimethoprim100MG · tablet;oral | Trimethoprim | Rx |
| Mar 12, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 19, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 15, 2011 | 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
