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FDA Drug Application 022574 by BAYER HLTHCARE

Application Number022574
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/16/2010N27300000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022574s000ltr.pdf 12/21/2010
AP012/16/2010N27348000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022574s000lbl.pdf 12/22/2010
AP012/16/2010N29517000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574_safyral_toc.cfm 7/15/2011
AP012/16/2010N29518000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022574Orig1s000SumR.pdf 7/15/2011
AP012/16/2010N30587000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm 11/16/2011
AP02/13/2012SE831781001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s001lbl.pdf 2/14/2012
AP02/13/2012SE831840001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022574s001ltr.pdf 2/21/2012
AP02/13/2012SE845101001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s001.pdf 2/3/2016
AP04/10/2012SLR45102004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022574Orig1s004.pdf 2/3/2016
AP04/10/2012SLR32386004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022574s004lbl.pdf 4/10/2012
AP04/10/2012SLR32407004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf 4/12/2012
AP06/1/2015SLR42972006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf 6/3/2015
AP06/1/2015SLR42992006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022574s006lbl.pdf 6/4/2015




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