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FDA Drug Application 022532 by BAYER HLTHCARE

Application Number022532
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
AP09/24/2010N26564000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022532s000ltr.pdf 9/29/2010
AP09/24/2010N26569000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf 9/29/2010
AP09/24/2010N28453000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022532_beyaz_toc.cfm 4/4/2011
AP09/24/2010N28454000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022532Orig1s000SumR.pdf 4/4/2011
AP09/24/2010N30588000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm 11/16/2011
AP02/13/2012SE831780001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf 2/14/2012
AP02/13/2012SE831839001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022532s001ltr.pdf 2/21/2012
AP02/13/2012SE845099001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s001.pdf 2/3/2016
AP04/10/2012SLR45100004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s004.pdf 2/3/2016
AP04/10/2012SLR32385004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf 4/10/2012
AP04/10/2012SLR32406004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf 4/12/2012
AP06/1/2015SLR42971006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf 6/3/2015
AP06/1/2015SLR42990006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf 6/4/2015
AP05/11/2016SCM       




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