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ビジネス · 2005/8/291 分で読めます

Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications

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概要

The Food and Drug Administration (FDA) is withdrawing approval of ten abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able Labs has initiated a class II recall of the products covered by these ANDAs. The company has requested that the applications be withdrawn and has waived its opportunity for a hearing.

情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →

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