The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the application...
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83 FR 35654
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“ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications,” thefederalregister.org (July 27, 2018), https://thefederalregister.org/documents/2018-16037/icu-medical-inc-et-al-withdrawal-of-approval-of-31-abbreviated-new-drug-applications.