The Food and Drug Administration (FDA or Agency) is withdrawing approval of 22 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 22 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the application...
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83 FR 2455
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“Delcor Asset Corp. et al.; Withdrawal of Approval of 22 Abbreviated New Drug Applications,” thefederalregister.org (January 17, 2018), https://thefederalregister.org/documents/2018-00695/delcor-asset-corp-et-al-withdrawal-of-approval-of-22-abbreviated-new-drug-applications.