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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207916Orig1s000 PHARMACOLOGY REVIEW(S) applicable to adult and pediatric patients, since the recipient dose in mg/kg will be similar throughout
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Application number - accessdata is a unique identifier assigned to each application filed with the accessdata system.
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The purpose of application number - accessdata is to track and identify each application submitted through the accessdata system.
The information required to be reported on application number - accessdata may vary depending on the specific application being filed, but typically includes applicant information, application details, and any supporting documentation.
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