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비즈니스 · 2023. 11. 17.1 분 읽기
Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction
로컬 자동 번역 · 원본 출처 언어
요약
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 8, 2022. The document announced the determination of the regulatory review period for ROZLYTREK INJECTION (entrectinib) for purposes of patent extension. The document was published with an incorrect dosage form. This notice corrects the dosage form of the drug product.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →