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FDA Drug Application 021338 by THE MEDICINES CO

Application Number021338
Application Type New Drug Application
Sponsor ApplicantTHE MEDICINES CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/22/2006N14164000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021338lbl.pdf 5/24/2006
AP05/22/2006N18876000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021338_toc.cfm 1/16/2008
AP05/22/2006N18877000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021338s000_Approv.pdf 1/16/2008
AP05/22/2006N43197000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=346 7/2/2015
AP04/30/2015SE842714005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021338Orig1s005ltr.pdf 5/4/2015
AP04/30/2015SE842742005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021338s005lbl.pdf 5/6/2015
AP011/12/2015SE844482006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021338Orig1s006ltr.pdf 11/16/2015




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