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비즈니스 · 2024. 10. 18.1 분 읽기
Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
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요약
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205851 and the new animal drug application (NADA) 141-389 for the designated medical gas Helium, USP held by Linde, Inc., 175 East Park Dr., Tonawanda, NY 14150-7844. Linde, Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →