The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) from multiple applicants. The applicants 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writi...
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83 FR 54355
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“Endo Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 10 New Drug Applications,” thefederalregister.org (October 29, 2018), https://thefederalregister.org/documents/2018-23528/endo-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-10-new-drug-applications.