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비즈니스 · 2019. 10. 28.1 분 읽기
InvaGen Pharmaceuticals, Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Trandolapril Tablets; Opportunity for a Hearing
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →