Entreprise · 23/10/19971 min de lecture
Helen A. Ballack Co. et al.; Withdrawal of Approval of 61 New Drug Applications, 8 Abbreviated Antibiotic Applications, and 36 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 September 25, 1997 (62 FR 50387). The document announced the withdrawal of approval of 61 new drug applications (NDA's), 8 abbreviated antibiotic applications (AADA's), and 36 abbreviated new drug applications (ANDA's). The document inadvertently withdrew approval of NDA 19-339 for Heparin Sodium in 5% Dextrose Injection in CR3 Flexible Container held by Abbott Laboratories, D-389 Bldg. AP30, 200 Abbott Park Rd., Abbott Park, IL 60064-3537. This document confirms that approval of NDA 19-339 is still in effect, and that the withdrawal of approval of the NDA was in error.