APPLICATION NUMBER: 125083Orig1s000 · 2011. 9. 16. · Hoffiann-La Roche (HLR) has submitted this...

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Transcript of APPLICATION NUMBER: 125083Orig1s000 · 2011. 9. 16. · Hoffiann-La Roche (HLR) has submitted this...

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 125083Orig1s000

OFFICE DIRECTOR MEMO