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CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-203 CROSS DISCIPLINE TEAM LEADER REVIEW

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 22-203

CROSS DISCIPLINE TEAM LEADER REVIEW

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · 10/17/2008, "The chemistry, manufacturing and controls (CMC) section of this NDA has been referenced to the Treanda NDA 22-249 submitted

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