125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9...

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

Transcript of 125557Orig1s000 - Food and Drug Administration · by 2 week Intervals. The starting dose is 9...

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)

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---------------------------------------------------------------------------------------------------------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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