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FDA Drug Application 022090 by BAYER HLTHCARE

Application Number022090
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/3/2008N20168000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022090lbl.pdf 7/9/2008
AP07/3/2008N20211000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022090s000ltr.pdf 7/15/2008
AP07/3/2008N20643000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000TOC.cfm 8/19/2008
AP07/3/2008N20644000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022090s000_SumR.pdf 8/19/2008
AP07/3/2008N31163000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 12/21/2011
AP011/13/2009SCM23974002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf 11/19/2009
AP02/4/2013SCM       
AP012/20/2010SLR27313004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022090s004lbl.pdf 12/20/2010
AP012/20/2010SLR27326004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022090s004ltr.pdf 12/22/2010
AP011/16/2011SLR30688005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022090s005ltr.pdf 11/21/2011
AP011/16/2011SLR30717005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022090s005lbl.pdf 11/21/2011
AP010/16/2013SLR37452008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022090Orig1s008ltr.pdf 10/18/2013
AP010/16/2013SLR37468008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022090s008lbl.pdf 10/18/2013
AP01/16/2014SCM       
AP03/27/2015SE842335011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022090Orig1s011ltr.pdf 4/1/2015
AP03/27/2015SE842368011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022090s011lbl.pdf 4/1/2015
AP010/26/2015SCM       




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