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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207958Orig1s000 CHEMISTRY REVIEW(S)

207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles

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Page 1: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207958Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 3: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 4: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 5: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 6: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 7: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 8: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 9: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 10: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 11: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 12: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 13: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 14: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 15: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 16: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 17: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 18: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 19: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 20: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 21: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 22: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 23: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 24: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 25: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 26: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 27: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 28: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 29: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 30: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 31: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 32: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles
Page 33: 207958Orig1s000 · 2014. 10. 1. · 5/28/2015 STATUSI Adequate TYPE Type 11 Type 111 Type 111 Type 111 Other ITEM HOLDER ... 439/CL-LEV-001 -ROOD was conducted to compare PK profiles

111111111~111~ 111~ 111111~1111111m ......111111111~111~ 111~ 111111111rn 111111~1111111m~11111111111111111111111 Doc ID: 002974840048 Type: MIS Recorded: 12/13/2005 at 01:13:18 PM

111111111~111~ 111~ 111111~1111111m ......111111111~111~ 111~ 111111111rn 111111~1111111m~11111111111111111111111 Doc ID: 002974840048 Type: MIS Recorded: 12/13/2005 at 01:13:18 PM

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