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Entreprise · 16/09/20191 min de lecture
Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →