Determination That FORADIL (Formoterol Fumarate) Inhalation Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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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.
The Food and Drug Administration (FDA, the Agency, or we) has determined that FORADIL (formoterol fumarate) inhalation powder, 0.012 milligrams (mg)/inhalation (inh), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for formoterol fumarate inhalation powder, 0.012 mg/inh, if all other legal and regulatory requirements are met.
Abstract as published in the Federal Register.
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