208351Orig1s000 - Food and Drug AdministrationQUALITY ASSESSMENT Recommendation: Approval NDA 208351...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208351Orig1s000 CHEMISTRY REVIEW(S)

Transcript of 208351Orig1s000 - Food and Drug AdministrationQUALITY ASSESSMENT Recommendation: Approval NDA 208351...

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CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208351Orig1s000

CHEMISTRY REVIEW(S)

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---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

ROBYN S JORDON03/09/2016

Reference ID: 3899564


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