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Entreprise · 02/11/20011 min de lecture
Schering Corp. et al.; Withdrawal of Approval of 51 New Drug Applications and 25 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 August 16, 2001 (66 FR 43017). The document announced the withdrawal of approval of 51 new drug applications (NDAs) and 25 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of NDA 17-255 for DTPA (chelate) Multidose (kit for the preparation of Tc-99m pentetate injection) held by Nycomed Amersham Imaging, 101 Carnegie Center, Princeton, NJ 08540. FDA confirms that approval of NDA 17-255 is still in effect.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →