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FDA Drug Application 021067 by MERCK SHARP DOHME

Application Number021067
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP03/30/2005N11336000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021067lbl.pdf 3/31/2005
AP03/30/2005N11337000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21067ltr.pdf 3/31/2005
AP03/30/2005N14428000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021067s000_AsmanexTOC.cfm 7/5/2006
AP02/1/2008SE526358003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s003ltr.pdf 9/2/2010
AP02/1/2008SE526359003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf 9/2/2010
AP02/26/2008SLR19334007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s007ltr.pdf 2/29/2008
AP09/17/2010SLR26504013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf 9/20/2010
AP09/17/2010SLR26515013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021067s013ltr.pdf 9/21/2010
AP08/3/2015SCM       




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