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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)

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Page 1: 207953Orig1s000 - Food and Drug Administration€¦ · Bio harmaceutics Business Process Mana er new NDA ro riet name ro uali res onse to IR quality response to IR labels, labelin

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207953Orig1s000

CHEMISTRY REVIEW(S)

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OFFICE OF PHARMACEUTICAL QUALITY FILING REVIEW

B. NOTEWORTHY ELEMENTS OF THE APPLICATION Yes No Comment

17. Biosimiliar product1 18. Combination Product _____________________ 19. Other_________________

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