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FDA Drug Application 206229 by MEDICINES360

Application Number206229
Application Type New Drug Application
Sponsor ApplicantMEDICINES360
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/26/2015N42100000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206229Orig1s000ltr.pdf 3/11/2015
AP02/26/2015N42188000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206229s000lbl.pdf 3/18/2015
AP02/26/2015N47187000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206229Orig1s000TOC.cfm 9/28/2016
AP01/29/2016SE845064001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206229Orig1s001ltr.pdf 2/1/2016
AP01/29/2016SE845088001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206229s001lbl.pdf 2/2/2016
AP05/31/2016SCM       
AP010/12/2016SCM       




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