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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208036Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 208036Orig1s000 - Food and Drug Administration · 2016. 11. 16. · substance), E-Z-EM of Canada (palT of release testing, stability testing, and final drug product). All issues for

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208036Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208036Orig1s000 - Food and Drug Administration · 2016. 11. 16. · substance), E-Z-EM of Canada (palT of release testing, stability testing, and final drug product). All issues for
Page 3: 208036Orig1s000 - Food and Drug Administration · 2016. 11. 16. · substance), E-Z-EM of Canada (palT of release testing, stability testing, and final drug product). All issues for
Page 4: 208036Orig1s000 - Food and Drug Administration · 2016. 11. 16. · substance), E-Z-EM of Canada (palT of release testing, stability testing, and final drug product). All issues for
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6

(b) (4)

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Reference ID: 3879821


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