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Entreprise · 02/01/20181 min de lecture
Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 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 October 24, 2017. The document announced the withdrawal of approval of 54 abbreviated new drug applications (ANDAs) from two applicants, effective November 24, 2017. The notice inadvertently announced the withdrawal of approval for ANDA 087296 for Chlorthalidone Tablets USP, 25 milligrams, held by Watson Laboratories, Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. FDA confirms that the approval of ANDA 087296 is still in effect.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →