207953Orig1s000 - Food and Drug Administration€¦ · Bio harmaceutics Business Process Mana er...
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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207953Orig1s000 CHEMISTRY REVIEW(S)
Transcript of 207953Orig1s000 - Food and Drug Administration€¦ · Bio harmaceutics Business Process Mana er...
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
207953Orig1s000
CHEMISTRY REVIEW(S)
OFFICE OF PHARMACEUTICAL QUALITY FILING REVIEW
B. NOTEWORTHY ELEMENTS OF THE APPLICATION Yes No Comment
17. Biosimiliar product1 18. Combination Product _____________________ 19. Other_________________