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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761044Orig1s000 PRODUCT QUALITY REVIEW(S)

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Page 1: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

761044Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 3: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 4: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 5: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 6: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 7: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 8: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 9: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
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Page 12: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 13: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 14: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 15: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 16: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 17: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 18: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 19: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 20: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 21: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 22: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 23: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 24: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 25: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 26: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 27: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 28: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 29: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 30: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 31: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 32: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 33: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 34: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 35: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 36: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
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Page 38: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency

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Page 39: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 40: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 41: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 42: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 43: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 44: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 45: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 46: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 47: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 48: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 49: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 50: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 51: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 52: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 53: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 54: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 55: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 56: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 57: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 58: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 59: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency
Page 60: 761044Orig1s000 - Food and Drug Administration · 1. Potency and Strength: Potency is defined as the percent activity relative to a qualified ustekinumab reference standard. The potency

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