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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208253Orig1s000 CHEMISTRY REVIEW(S)

208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),

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Page 1: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208253Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 3: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 4: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 5: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 6: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 7: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 8: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 9: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 10: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 11: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 12: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 13: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 14: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 15: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 16: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 17: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 18: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 19: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 20: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 21: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 22: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 23: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 24: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 25: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 26: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 27: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 28: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 29: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),
Page 30: 208253Orig1s000€¦ · The Applicant claims that, based on the provided data (previously obtained by other laboratories and from the Applicant's supplementary method validation studies),

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

NICOLA M FENTY-STEWART09/11/2015

Reference ID: 3818558


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