Determination That BACTROBAN (Mupirocin) Nasal Ointment, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
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The Food and Drug Administration (FDA or Agency) has determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn from sale for reasons of safety or effectiveness.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.
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