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Negócios · 23/06/19941 min de leitura
Clay-Park Labs, Inc.; Withdrawal of Approval of Three Abbreviated Applications
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Resumo
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.
Idioma original da fonte: Federal Register — Health and Human ServicesAbrir o comunicado original →