39
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208051Orig1s000 PRODUCT QUALITY REVIEW(S)

208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res

  • Upload
    others

  • View
    6

  • Download
    0

Embed Size (px)

Citation preview

Page 1: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208051Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 3: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 4: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 5: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 6: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 7: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 8: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 9: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 10: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 11: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res

XiaoChen

Digitally signed by Xiao Chen

Date: 6/21/2017 04:02:08PM

GUID: 508da7220002a138fcc70fbccbfd08bf

Page 12: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 13: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 14: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res

RaananBloom

Digitally signed by Raanan Bloom

Date: 6/13/2017 02:02:39PM

GUID: 508da72a0002a6d1071f3297897e4f1f

MichaelFurness

Digitally signed by Michael Furness

Date: 6/13/2017 03:29:50PM

GUID: 502e8c7600003dd8331cf6eebf43697a

Page 15: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 16: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 17: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 18: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 19: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 20: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 21: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 22: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 23: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 24: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 25: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 26: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 27: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 28: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res

AmitMitra

Digitally signed by Amit Mitra

Date: 5/10/2017 10:05:38AM

GUID: 502d1ab500002af97e86c5f6f3951edc

AnamitroBanerjee

Digitally signed by Anamitro Banerjee

Date: 5/10/2017 10:11:07AM

GUID: 5075764700003844b7bc89632228509f

Page 29: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 30: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 31: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 32: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 33: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 34: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 35: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 36: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 37: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 38: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res
Page 39: 208051Orig1s000 - Food and Drug AdministrationDS/DP/Process/Bi0 ham./Faci1i /EA DS/Process/Bio hann DS Bio hann. ... li 0035 36 li 0008 9 Quality Response 0008 (9) Res onse 0008 Res

ZhuojunZhao

Digitally signed by Zhuojun Zhao

Date: 3/23/2017 01:22:11PM

GUID: 508da6fd000284770cf4eecbae074722

OkponanabofaEradiri

Digitally signed by Okponanabofa Eradiri

Date: 3/23/2017 01:30:42PM

GUID: 50bdfe8d00003559ede66be3fd299f65