> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Hydrocortone Not Withdrawn Over Safety/Efficacy
- URL: https://www.fdaweb.com/hydrocortone-not-withdrawn-over-safety-efficacy/
- Published: 2024-11-18T12:00:00.000Z
- Updated: 2026-09-14T14:47:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158202

*Federal Register* notice: FDA has determined that Merck’s Hydrocortone (hydrocortisone sodium phosphate) injection, equivalent to 50 mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Hydrocortone is a synthetic glucocorticoid for use as an anti-inflammatory or immunosuppressant agent. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-26916.pdf?ref=fdaweb.com).