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FDA Drug Application 021844 by BAYER HLTHCARE

Application Number021844
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP010/20/2006N15137000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021844lbl.pdf 10/23/2006
AP010/20/2006N15167000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021844s000ltr.pdf 10/23/2006
AP010/20/2006N20744000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021844_desonate_toc.cfm 9/5/2008
AP012/29/2009SLR24431002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021844s002ltr.pdf 1/5/2010
AP012/29/2009SLR24491002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021844s002lbl.pdf 1/12/2010
AP07/22/2014SLR39964008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021844Orig1s008ltr.pdf 7/24/2014
AP07/22/2014SLR39974008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021844s008lbl.pdf 7/24/2014
AP01/12/2015SCM       
AP03/14/2016SCM       




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