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DESI withdrawals

Executive Summary

FDA is providing opportunities for hearings on its proposals to withdraw approval of 25 ANDAs for certain single-entity coronary vasodilator products containing isosorbide dinitrate, and for one NDA and five ANDAs for certain nitroglycerin transdermal systems. The agency is proposing to withdraw approval for the products because the sponsors failed to submit bioequivalency/bioavailability data required under the Drug Efficacy Study Implementation program. Several of the products listed in the March 22 and March 25 Federal Register notices are no longer being marketed, sponsors indicated

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