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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209512Orig1s000 CLINICAL REVIEW(S)

209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination

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Page 1: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209512Orig1s000

CLINICAL REVIEW(S)

Page 2: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 3: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 4: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 5: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 6: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 7: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 8: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 9: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 10: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 11: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 12: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 13: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 14: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 15: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 16: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 17: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 18: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 19: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 20: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 21: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination
Page 22: 209512Orig1s000 - Food and Drug Administration · Abbvie December 7, 2016 June 7, 2017 Norvir (ritonavir [R TV]) Oral Powder NORVIR Powder for Oral Suspension is indicated in combination

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

M R ALIVISATOS05/09/2017

ADAM I SHERWAT05/09/2017

Reference ID: 4095586


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