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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207968Orig1s000 PRODUCT QUALITY REVIEW(S)

207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

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Page 1: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

207968Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 3: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 4: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 5: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 6: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 7: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 8: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

SheritaMcLamore

Digitally signed by Sherita McLamore

Date: 4/19/2017 10:53:12AM

GUID: 503257950000415755492db5bb8b1a5c

58 Pages have been Withheld in Full as B4 (CCI/TS) Immediately Following this Page

Page 9: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 10: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 11: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 12: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 13: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 14: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 15: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 16: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 17: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 18: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 19: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 20: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

AmitMitra

Digitally signed by Amit Mitra

Date: 4/07/2017 01:47:10PM

GUID: 502d1ab500002af97e86c5f6f3951edc

AnamitroBanerjee

Digitally signed by Anamitro Banerjee

Date: 4/07/2017 12:55:39PM

GUID: 5075764700003844b7bc89632228509f

Comments: Updated the document with my signature

43 Pages have been Withheld in Full as B4 (CCI/TS) Immediately Following this

Page

Page 21: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 22: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 23: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 24: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 25: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 26: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

BanuZolnik

Digitally signed by Banu Zolnik

Date: 4/11/2017 11:42:30AM

GUID: 508da7270002a568e175a2c0dd90f334

OkponanabofaEradiri

Digitally signed by Okponanabofa Eradiri

Date: 4/11/2017 12:04:58PM

GUID: 50bdfe8d00003559ede66be3fd299f65

9 Pages have been Withheld in Full as B4 (CCI/TS) Immediately Following this

Page

Page 27: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 28: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 29: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 30: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 31: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;
Page 32: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

NealSweeney

Digitally signed by Neal Sweeney

Date: 9/20/2016 12:48:40PM

GUID: 508da70c00028f5119acd77351f33159

YuanshaChen

Digitally signed by Yuansha Chen

Date: 9/19/2016 03:49:56PM

GUID: 545289f5000727e1136ef94794e114b8

Page 33: 207968Orig1s000...and molecular weight of 373.4. JADENU granules contain 90 mg, 180 mg, or 360 mg deferasirox. Inactive ingredients include microcrystalline cellulose, crospovidone;

SheritaMcLamore

Digitally signed by Sherita McLamore

Date: 4/19/2017 11:12:31AM

GUID: 503257950000415755492db5bb8b1a5c


World Bank Document...Interest during construction 2.9 10.0 12.9 Total Financing Required 239.9 133.5 373.4 La Includes taxes and duties estimated at $24.9 million equivalent, land

World Bank Document...Interest during construction 2.9 10.0 12.9 Total Financing Required 239.9 133.5 373.4 La Includes taxes and duties estimated at $24.9 million equivalent, land

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