Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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The Food and Drug Administration (FDA or Agency) has determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
- Tags
- information blocking, Notice, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISSP 1: Security and Risk Management
- Source record id
- 2026-08939
- First seen by InfoSec Signals
- Sep 23, 2026
Source: Federal Register API, Office of the Federal Register, National Archives and Records Administration about this source more from it
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