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비즈니스 · 2014. 3. 10.1 분 읽기
MK Laboratories, Inc., et al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications for Propoxyphene Products; Opportunity for a Hearing
로컬 자동 번역 · 원본 출처 언어
요약
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.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →