Cette traduction est en cours de préparation. En attendant, nous affichons temporairement la version originale en anglais.
Entreprise · 21/07/19971 min de lecture
Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications; Correction
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 25, 1997 (62 FR 34297). The document announced the withdrawal of approval of 39 new drug applications (NDA's), 13 abbreviated antibiotic applications (AADA's), and 46 abbreviated new drug applications (ANDA's). The document inadvertently withdrew approval of NDA 50-678 for DYNABAC (dirithromycin tablets) held by Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285. This document confirms that approval of NDA 50-678 is still in effect, and that the withdrawal of approval of the NDA was in error.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →