center for drug evaluation and research · dec. 20, 2007: stn bl 103234/5166 submitted (received by...

40
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 103234Orig1s5166 SUMMARY REVIEW

Upload: others

Post on 24-Sep-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER: 103234Orig1s5166

SUMMARY REVIEW

Page 2: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 3: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 4: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 5: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 6: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 7: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 8: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 9: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 10: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 11: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 12: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 13: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 14: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 15: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 16: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 17: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 18: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 19: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 20: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 21: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 22: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 23: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 24: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 25: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 26: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 27: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 28: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 29: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 30: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 31: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 32: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 33: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 34: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 35: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 36: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 37: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 38: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 39: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008:
Page 40: CENTER FOR DRUG EVALUATION AND RESEARCH · Dec. 20, 2007: STN BL 103234/5166 submitted (received by FDA on Dec. 26, 2007). Feb. I, 2008: Acknowledgment letter issued. Feb 21 , 2008: