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FDA Drug Application 021605 by MERCK SHARP DOHME

Application Number021605
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
AP03/3/2005N11227000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021605ltr.pdf 3/10/2005
AP03/3/2005N11228000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf 3/10/2005
AP03/3/2005N16460000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021605s000TOC.cfm 5/9/2007
AP012/30/2009SLR24430006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021605s006ltr.pdf 1/5/2010
AP012/30/2009SLR24495006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf 1/12/2010
AP03/7/2014SLR38729012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021605Orig1s012ltr.pdf 3/10/2014
AP03/7/2014SLR38735012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf 3/10/2014




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