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ビジネス · 1994/6/231 分で読めます

Clay-Park Labs, Inc.; Withdrawal of Approval of Three Abbreviated Applications

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概要

The Food and Drug Administration (FDA) is withdrawing approval of one abbreviated antibiotic drug application (AADA) and two abbreviated new drug applications (ANDA's) held by Clay-Park Labs, Inc., 1700 Bathgate Ave., Bathgate Industrial Park, Bronx, NY 10457 (Clay-Park). FDA is withdrawing approval of these applications because of questions raised about the reliability of the data and information submitted to FDA in support of the applications. Clay-Park requested this withdrawal and in so doing has waived its opportunity for a hearing.

情報源の原言語: Federal Register — Health and Human Services原文の発表を開く →

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