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Negócios · 10/03/20141 min de leitura
MK Laboratories, Inc., et al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications for Propoxyphene Products; Opportunity for a Hearing
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three abbreviated new drug applications (ANDAs) for propoxyphene drug products from multiple sources and is announcing an opportunity for holders of those ANDAs to request a hearing on this proposal.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →