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# Chlor–Trimeton Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/chlor-trimeton-not-withdrawn-due-to-safety-efficacy/
- Published: 2019-04-03T12:00:00.000Z
- Updated: 2026-09-15T01:18:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143774

*Federal Register* notice: FDA has determined that Bayer’s Chlor–Trimeton Allergy 12 Hour (chlorpheniramine maleate) extended release tablets 8mg and 12mg were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-04-02/pdf/2019-06382.pdf?ref=fdaweb.com).