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FDA Drug Application 206316 by DAIICHI SANKYO

Application Number206316
Application Type New Drug Application
Sponsor ApplicantDAIICHI SANKYO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/8/2015N43124000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s000ltr.pdf 1/9/2015
AP01/8/2015N43125000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf 1/9/2015
AP01/8/2015N43126000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000TOC.cfm 2/13/2015
AP01/8/2015N43127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000SumR.pdf 2/13/2015
AP01/8/2015N43128000   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm 1/9/2015
AP01/8/2015N43129000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf 1/9/2015
AP01/8/2015N43130000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000SumR.pdf 2/13/2015
AP01/8/2015N43131000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000TOC.cfm 2/13/2015
AP11/8/2015N43124000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s000ltr.pdf 1/9/2015
AP11/8/2015N43125000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf 1/9/2015
AP11/8/2015N43126000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000TOC.cfm 2/13/2015
AP11/8/2015N43127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000SumR.pdf 2/13/2015
AP11/8/2015N43128000   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm 1/9/2015
AP11/8/2015N43129000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf 1/9/2015
AP11/8/2015N43130000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000SumR.pdf 2/13/2015
AP11/8/2015N43131000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206316Orig1Orig2s000TOC.cfm 2/13/2015
AP08/24/2015SCM       
AP09/10/2015SLR43849002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316s002lbl.pdf 9/11/2015
AP09/10/2015SLR43859002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig1s002ltr.pdf 9/14/2015
AP010/30/2015SCM       
AP09/15/2016SLR47070004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206316Orig1s004ltr.pdf 9/19/2016
AP09/15/2016SLR47098004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206316s004lbl.pdf 9/20/2016
AP011/6/2015SCM       
AP010/16/2015SCM44280006   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467811.pdf 10/23/2015
AP04/25/2016SCM       




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