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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206995Orig1s000 CHEMISTRY REVIEW(S)

206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature

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Page 1: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

206995Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 3: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 4: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 5: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 6: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 7: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature

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

MARY GRACE LUBAO07/21/2015

Reference ID: 3795353

Page 8: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 9: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 10: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 11: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 12: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 13: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 14: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 15: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 16: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 17: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 18: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 19: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature
Page 20: 206995Orig1s000 - Food and Drug AdministrationThis is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature