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Page 1: 125399Orig1s000 - Food and Drug Administration€¦ · center for drug evaluation and research application number: 125399orig1s000 summary review

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125399Orig1s000

SUMMARY REVIEW

Page 2: 125399Orig1s000 - Food and Drug Administration€¦ · center for drug evaluation and research application number: 125399orig1s000 summary review
Page 3: 125399Orig1s000 - Food and Drug Administration€¦ · center for drug evaluation and research application number: 125399orig1s000 summary review
Page 4: 125399Orig1s000 - Food and Drug Administration€¦ · center for drug evaluation and research application number: 125399orig1s000 summary review

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Page 5: 125399Orig1s000 - Food and Drug Administration€¦ · center for drug evaluation and research application number: 125399orig1s000 summary review

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