federal_register: E9-28871

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-28871 Determination That ABILIFY DISCMELT (Aripiprazole) Orally Disintegrating Tablets, 20 Milligrams and 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 milligrams (mg) and 30 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for aripiprazole orally disintegrating tablets, 20 mg and 30 mg, if all other legal and regulatory requirements are met. 2009-12-03 2009 12 https://www.federalregister.gov/documents/2009/12/03/E9-28871/determination-that-abilify-discmelt-aripiprazole-orally-disintegrating-tablets-20-milligrams-and-30 https://www.govinfo.gov/content/pkg/FR-2009-12-03/pdf/E9-28871.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that ABILIFY DISCMELT (aripiprazole) orally disintegrating tablets, 20 milligrams (mg) and 30 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow...

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