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商业 · 2018/1/21 分钟阅读
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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摘要
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.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →