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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125557Orig1s000 CHEMISTRY REVIEW(S)

125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

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Page 1: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125557Orig1s000

CHEMISTRY REVIEW(S)

Page 2: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 3: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 4: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 5: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 6: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 7: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 8: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 9: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 10: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 11: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 12: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 13: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 14: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 15: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 16: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 17: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 18: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 19: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

Page 20: 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9 pg/day for one week followed by 28 pg./day from week 2 flu-ough week 4. All subsequent

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

QING ZHOU09/29/2014

DEBORAH H SCHMIEL09/29/2014

RASHMI RAWAT09/29/2014

Reference ID: 3636437

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