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FDA Drug Application 021400 by BAYER HLTHCARE

Application Number021400
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
AP08/19/2003N6571000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21400ltr.pdf 8/28/2003
AP08/19/2003N6572000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21400_levitra_lbl.pdf 8/28/2003
AP08/19/2003N6845000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-400_Levitra.cfm 10/29/2003
AP08/19/2003N18245000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106517.htm 10/18/2007
AP05/13/2005SLR11633002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021400s002ltr.pdf 5/17/2005
AP05/13/2005SLR11657002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s002lbl.pdf 5/17/2005
AP07/8/2005SLR11965004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021400s004lbl.pdf 7/8/2005
AP07/8/2005SLR12004004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021400s004ltr.pdf 7/15/2005
AP04/6/2007SLR16183008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s008lbl.pdf 4/9/2007
AP04/6/2007SLR16255008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021400s008ltr.pdf 4/20/2007
AP010/18/2007SLR18248010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021400s010lbl.pdf 10/18/2007
AP010/18/2007SLR18271010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021400s010ltr.pdf 10/22/2007
AP03/19/2008SLR19496011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021400s011lbl.pdf 3/20/2008
AP03/19/2008SLR19500011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021400s011ltr.pdf 3/21/2008
AP05/15/2008SLR19855012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021400s012ltr.pdf 5/21/2008
AP011/22/2011SLR30777013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021400s013ltr.pdf 11/28/2011
AP011/22/2011SLR30814013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021400s013lbl.pdf 11/30/2011
AP08/2/2013SE836692016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021400Orig1s016ltr.pdf 8/5/2013
AP08/2/2013SE836705016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021400s016lbl.pdf 8/6/2013
AP04/29/2014SLR39182017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021400Orig1s017ltr.pdf 4/30/2014
AP04/29/2014SLR39207017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021400s017lbl.pdf 5/2/2014
AP011/3/2014SCM       
AP09/16/2015SLR43910019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021400Orig1s019ltr.pdf 9/17/2015
AP09/16/2015SLR43951019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/21400s019lbl.pdf 9/23/2015




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