2025-16863: Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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Food and Drug Administration (FDA or Agency) has determined that NUTRACORT (hydrocortisone) topical gel, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, 1%, if all other legal and regulatory requirements are met.
The agency’s own summary, as published.
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