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FEDERAL REGISTER · NOTICEDecember 12, 2025

Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Document type
Notice
Agency
Health and Human Services Department
Published
December 12, 2025
Document number
2025-22682
ABSTRACT

The Food and Drug Administration (FDA or Agency) has determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mupirocin nasal ointment, 2%, if all other legal and regulatory requirements are met.

Abstract as published in the Federal Register.

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.