The Food and Drug Administration (FDA) is withdrawing approval of 67 new drug applications (NDAs) and 128 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Document
Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 67 new drug applications (NDAs) and 128 abbreviated new drug applications (ANDAs) from multiple applicants. The...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 61426
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications,” thefederalregister.org (October 13, 2015), https://thefederalregister.org/documents/2015-25922/organon-usa-inc-et-al-withdrawal-of-approval-of-67-new-drug-applications-and-128-abbreviated-new-drug-applications.