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Negócios · 16/09/20191 min de leitura
Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
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Resumo
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 5, 2019. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, effective March 7, 2019. The document erroneously included ANDA 077895 for Ursodiol Capsules USP, 300 milligrams, held by Impax Laboratories, LLC. This notice corrects that error.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →