The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the ...
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83 FR 64131
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“Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications,” thefederalregister.org (December 13, 2018), https://thefederalregister.org/documents/2018-26947/allied-pharma-inc-et-al-withdrawal-of-approval-of-nine-abbreviated-new-drug-applications.