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FDA Drug Application 206334 by THE MEDICINES CO

Application Number206334
Application Type New Drug Application
Sponsor ApplicantTHE MEDICINES CO
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
AP08/6/2014N40175000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206334Orig1s000ltr.pdf 8/7/2014
AP08/6/2014N40180000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206334s000lbl.pdf 8/8/2014
AP08/6/2014N40412000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206334Orig1s000TOC.cfm 9/5/2014
AP08/6/2014N40413000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206334Orig1s000SumR.pdf 9/5/2014
AP07/14/2015SCM       
AP01/20/2016SLR44997002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s002ltr.pdf 1/21/2016
AP01/20/2016SLR45026002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s002lbl.pdf 1/26/2016
AP010/17/2016SLR47390003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206334Orig1s003ltr.pdf 10/19/2016
AP010/17/2016SLR47394003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206334s003lbl.pdf 10/19/2016




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