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http://www.accessdata.fda.gov/sc ... ovalHistory#apphist Letter (PDF) ·ÂÖÆÒ©Åú×¼ÐÅÏ¢ We noted that the reference listed drug product (RLD) upon whichyou have based this application, Mivacron (Mivacurium Chloride)Injection, 2 mg (base)/mL, of Abbott Laboratories, is no longerbeing marketed in the United States. Thus, Abbott¡¯s Mivacron(Mivacurium Chloride) Injection, 2 mg (base)/mL, was moved fromthe Active to the Discontinued section of the agency¡¯spublication titled Approved Drug Products with TherapeuticEquivalence Evaluations, the ¡°Orange Book¡±. Subsequently, in aFederal Register Notice dated August 8, 2007 (Volume 72, No.152), the agency announced its determination that Abbott¡¯sMivacron (Mivacurium Chloride) Injection, 2 mg (base)/mL, wasnot withdrawn from sale for reasons of safety or effectiveness.This determination allows the agency to approve ANDAs for thediscontinued drug product. Æäʵ×Ô2006Ä꿪ʼ2mg/mlµÄÒѾ²»ÔÚÃÀ¹úÉÏÊÐÁË¡£ |
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