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# Plasma Lyte Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/plasma-lyte-not-withdrawn-due-to-safety-efficacy/
- Published: 2018-08-24T12:00:00.000Z
- Updated: 2026-09-15T00:28:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142191

*Federal Register* notice: FDA has determined that Plasma – Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDA approvals that reference the drug products, and it will allow the agency to continue to approve ANDAs that reference them as long as they meet relevant legal and regulatory requirements. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-08-24/pdf/2018-18311.pdf?ref=fdaweb.com).