Notice 3 Sep 2025 regulations, fda, pharmaceutical, drug approvals, hydrocortisone

💊FDA Determines NUTRACORT Gel Not Withdrawn for Safety Reasons

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Food and Drug Administration (FDA or Agency) has determined that NUTRACORT (hydrocortisone) topical gel, 1%, was not withdrawn from sale for reasons of safety or effectiveness.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.

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