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비즈니스 · 2007. 5. 25.1 분 읽기
Determination of Regulatory Review Periods for Purposes of Patent Extension; SPRYCEL-New Drug Applications 21-986 and 22-072
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCEL--new drug applications (NDAs) 21- 986 and 22-072 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →