center for drug evaluation and research...9/2/2016 10:05 am facility status app rove facility...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125319Orig1s085, 086, 087 PRODUCT QUALITY REVIEW(S)

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Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125319Orig1s085, 086, 087

PRODUCT QUALITY REVIEW(S)

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion
Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH...9/2/2016 10:05 AM Facility Status App rove Facility Approve Facflity App .x»ve FacÐity A rove Vacuity Approve Facaity Approve FacNity Completion