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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF BIOSTATISTICS STATISTICAL REVIEW AND E VA L U A T I O N CLINICAL STUDIES NDA/Serial Number: Drug Name: Indication(s): 21-538/N-000 AccretropinTM (Somatropin rDNA origin for Injection) (A) treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous...
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ucm072824
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