207071orig1s000€¦ · recommendation of "acceptable" from the office of process and...

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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207071Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207071Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 3: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 4: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 5: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 6: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 7: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 8: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 9: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 10: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 11: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 12: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 13: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 14: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 15: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 16: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 17: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

Reference ID: 3803436

Page 18: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 19: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 20: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 21: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 22: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 23: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 24: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 25: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 26: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 27: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 28: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 29: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 30: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 31: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 32: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate
Page 33: 207071Orig1s000€¦ · recommendation Of "Acceptable" from the Office of Process and Facilities in Panorama). Recommendation: ... Contents under pressure. Do not puncture or incinerate

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

CHRISTINA A CAPACCI-DANIEL11/24/2014

MAHESH R RAMANADHAM11/24/2014

Reference ID: 3656330