209115orig1s000 - food and drug administration · 6/23/2016  · quality assessment recommendation:...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209115Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 209115Orig1s000 - Food and Drug Administration · 6/23/2016  · QUALITY ASSESSMENT Recommendation: Approval Drug Name/Dosage Form Stren Route of Administration NDA 209115 Review

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209115Orig1s000

CHEMISTRY REVIEW(S)

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