federal_register: E7-3713

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-3713 Determination That LAMICTAL (Lamotrigine) Tablets, 50 Milligrams and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that LAMICTAL (lamotrigine) tablets, 50 milligrams (mg) and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 lamotrigine tablets, 50 mg and 250 mg, if all other legal and regulatory requirements are met. 2007-03-05 2007 3 https://www.federalregister.gov/documents/2007/03/05/E7-3713/determination-that-lamictal-lamotrigine-tablets-50-milligrams-and-250-milligrams-were-not-withdrawn https://www.govinfo.gov/content/pkg/FR-2007-03-05/pdf/E7-3713.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that LAMICTAL (lamotrigine) tablets, 50 milligrams (mg) and 250 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new...

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