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İş dünyası · 19.10.20231 dk okuma

American Regent, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications

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Özet

The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →