Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

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or Agency) has determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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

9/23/2026

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