The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) from multiple applicants. The holders of the applications notified th...
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83 FR 32305
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“Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications,” thefederalregister.org (July 12, 2018), https://thefederalregister.org/documents/2018-14935/concordia-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-29-new-drug-applications.