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FDA Drug Application 021884 by INSMED

Application Number021884
Application Type New Drug Application
Sponsor ApplicantINSMED
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/12/2005N13258000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021884lbl.pdf 12/15/2005
AP012/12/2005N13272000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021884ltr.pdf 12/15/2005
AP012/12/2005N13473000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021884_s000_IplexTOC.cfm 1/20/2006
AP02/27/2007SCS15966001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021884s001ltr.pdf 3/6/2007
AP02/27/2007SCS16001001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021884s001lbl.pdf 3/7/2007
AP02/27/2007SCS40147001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021884Orig1s001.pdf 8/5/2014
AP09/21/2006SLR14958002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021884s002ltr.pdf 9/25/2006




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