The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The...
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81 FR 68427
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“Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications,” thefederalregister.org (October 4, 2016), https://thefederalregister.org/documents/2016-23893/hospira-inc-et-al-withdrawal-of-approval-of-44-new-drug-applications-and-158-abbreviated-new-drug-applications.