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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208313Orig1s000 CHEMISTRY REVIEW(S)

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Page 1: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208313Orig1s000

CHEMISTRY REVIEW(S)

Page 2: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 3: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 4: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 5: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 6: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 7: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 8: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 9: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 10: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 11: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical

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Page 12: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical

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Page 13: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 14: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 15: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical

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Page 16: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 17: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 18: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 19: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 20: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 21: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 22: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 23: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 24: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 25: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 26: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical

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Page 27: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 28: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical

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Page 29: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 30: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 31: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 32: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 33: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 34: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 35: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 36: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 37: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 38: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 39: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 40: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 41: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 42: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 43: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 44: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 45: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 46: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 47: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 48: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 49: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 50: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 51: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 52: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 53: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 54: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 55: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical
Page 56: Chemistry Review(s)23, 2018 with the chssification ofOAI and re-classified to VAI by OMQ. The site has acceptable SVS profile. Based on the htest inspectbn result, Sun Pharmaceutical