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Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
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概要
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 11, 2009. The document announced the withdrawal of approval of 103 new drug applications and 35 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 13, 2009. The document erroneously included ANDA 75-108. The correct ANDA is ANDA 76-108 for Amiodarone hydrochloride (HCl) injection, 50 milligrams (mg)/milliliter (mL), held by Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046. This document corrects that error.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →