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商业 · 2012/4/251 分钟阅读
Sanofi-aventis, U.S., LLC; Withdrawal of Approval of a New Drug Application for OFORTA
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摘要
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for OFORTA (fludarabine phosphate) Tablets held by sanofi-aventis, U.S., LLC (sanofi-aventis), 55 Corporate Dr., Bridgewater, NJ 08807-0977. Sanofi-aventis has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →