The Food and Drug Administration (FDA or Agency) is withdrawing approval of four 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four new drug applications (NDAs) from multiple applicants. The holders of the applications notified ...
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83 FR 39103
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“Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications,” thefederalregister.org (August 8, 2018), https://thefederalregister.org/documents/2018-16982/merck-sharp-and-dohme-corporation-et-al-withdrawal-of-approval-of-four-new-drug-applications.