federal_register: 2015-29639

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2015-29639 Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA or Agency) has determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 ezetimibe and atorvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, if all other legal and regulatory requirements are met. 2015-11-20 2015 11 https://www.federalregister.gov/documents/2015/11/20/2015-29639/determination-that-liptruzet-ezetimibe-and-atorvastatin-tablets-10-milligrams10-milligrams-10 https://www.govinfo.gov/content/pkg/FR-2015-11-20/pdf/2015-29639.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) has determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were not withdrawn from sale for reasons of safety or...

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