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FDA Drug Application 204369 by BAYER HEALTHCARE PHARMS

Application Number204369
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/25/2013N35234000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204369lbl.pdf 2/25/2013
AP02/25/2013N35244000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204369Orig1s000ltr.pdf 2/26/2013
AP02/25/2013N38228000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000TOC.cfm 1/7/2014
AP02/25/2013N38229000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000SumR.pdf 1/7/2014




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