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FDA Drug Application 021355 by BAYER HLTHCARE

Application Number021355
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/28/2005N12833000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf 9/30/2005
AP09/28/2005N12934000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021355ltr.pdf 10/20/2005
AP09/28/2005N17821000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021355s000TOC.cfm 9/11/2007
AP02/29/2012SLR31983002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf 3/1/2012
AP02/29/2012SLR31987002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s002ltr.pdf 3/2/2012
AP02/29/2012SE231982003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf 3/1/2012
AP02/29/2012SE231986003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s003ltr.pdf 3/2/2012
AP01/26/2015SCM       
AP06/30/2015SLR43173006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf 7/1/2015
AP06/30/2015SLR43279006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021355Orig1s006ltr.pdf 7/9/2015




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