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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125359Orig1s000 SUMMARY REVIEW

125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination

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Page 1: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125359Orig1s000

SUMMARY REVIEW

Page 2: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 3: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 4: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 5: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 6: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 7: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 8: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 9: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 10: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 11: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 12: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 13: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 14: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 15: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 16: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 17: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 18: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 19: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 20: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 21: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 22: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 23: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 24: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 25: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination
Page 26: 125359Orig1s000 - Food and Drug Administration · PDF filespecifications for the IEX method and additional information on the Km/Kcat testing. ... cautioning that a final determination

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