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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125387Orig1s000 CHEMISTRY REVIEW(S)

125387Orig1s000 - Food and Drug Administration...SUMMARY BLA 125387 DEPARTMENT OF HEALTH & HUMAN SERVICES Center for Drugs Evaluation and Research — Food and Drug Administration

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Page 1: 125387Orig1s000 - Food and Drug Administration...SUMMARY BLA 125387 DEPARTMENT OF HEALTH & HUMAN SERVICES Center for Drugs Evaluation and Research — Food and Drug Administration

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125387Orig1s000

CHEMISTRY REVIEW(S)

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