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NDA 022374 was withdrawn on February 4 2011. NDA 203585 Cephalon was submitted on March 30 2012 and was designated as standard review. On May 24 2012 the Division of Hematology Products DHP requested that the for omacetaxine mepesuccinate. CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER 203585Orig1s000 OTHER REVIEW S PMR/PMC Development Template This template should be reviewed by the PMR/PMC Development Coordinator and included for each PMR/PMC in the Action Package. Agreement...
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