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FDA Drug Application 021277 by BAYER HLTHCARE

Application Number021277
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
AP011/30/2001N4597000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21277_Avelox_Approv.PDF 11/30/2001
AP011/30/2001N4598000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21277lbl.pdf 11/30/2001
AP011/30/2001N8781000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21277_Avelox.cfm 5/27/2004
AP011/30/2001N34824000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231731.pdf 1/3/2013
AP05/22/2002SLR4596001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21277s001ltr.pdf 5/22/2002
AP06/12/2002SLR4590002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf 6/12/2002
AP06/12/2002SLR4591002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf 6/12/2002
AP05/16/2002SLR4594003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-085s012ltr.pdf 5/16/2002
AP05/16/2002SLR4595003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s12lbl.pdf 5/16/2002
AP012/10/2002SCS       
AP02/28/2003SLR3860006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf 2/28/2003
AP02/28/2003SLR4246006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 3/10/2003
AP02/28/2003SE14247007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 3/10/2003
AP02/28/2003SE13861007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf 2/28/2003
AP02/28/2003SE119155007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021277_S007_AVELOX.pdf 2/19/2008
AP02/28/2003SLR3862009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf 2/28/2003
AP02/28/2003SLR4248009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 3/10/2003
AP010/6/2003SLR6762011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr019ltr.pdf 10/6/2003
AP010/6/2003SLR6783011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21277slr011,21085slr019_avelox_lbl.pdf 10/10/2003
AP05/18/2004SE119142017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021277_S017_AVELOX_TABLETS.pdf 2/19/2008
AP05/18/2004SE18642017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-022,21277se1-017ltr.pdf 5/26/2004
AP05/18/2004SE18714017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf 5/27/2004
AP03/6/2004SLR7846018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277slr018,21085slr023ltr.pdf 3/10/2004
AP03/6/2004SLR8227018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf 4/5/2004
AP07/28/2004SLR9912019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277s019,21085s024ltr.pdf 7/30/2004
AP07/28/2004SLR9921019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf 7/30/2004
AP06/13/2005SE111801022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022ltr.pdf 6/14/2005
AP06/13/2005SE111810022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf 6/14/2005
AP011/22/2005SE113143024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf 11/30/2005
AP011/22/2005SE113163024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf 11/30/2005
AP011/22/2005SLR13164025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf 11/30/2005
AP011/22/2005SLR13144025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf 11/30/2005
AP05/31/2007SLR16671030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021085s036,021277s030ltr.pdf 6/4/2007
AP05/31/2007SLR16688030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021085s036,021277s030lbl.pdf 6/4/2007
AP02/15/2008SLR19237031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021277s031ltr.pdf 2/20/2008
AP02/15/2008SLR19269031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf 2/25/2008
AP012/29/2008SLR21434033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039, 021277s033ltr.pdf 12/31/2008
AP012/29/2008SLR21465033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf 1/2/2009
AP010/3/2008SLR20969034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s040, 021277s034ltr.pdf 10/7/2008
AP010/3/2008SLR21003034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s040,021277s034lbl.pdf 10/9/2008
AP06/24/2009SLR22834035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s041,021277s035ltr.pdf 6/29/2009
AP04/27/2009SLR22423036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036ltr.pdf 5/5/2009
AP04/27/2009SLR22583036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf 5/15/2009
AP010/25/2010SLR26779038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021277s038lbl.pdf 10/25/2010
AP010/25/2010SLR26857038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s044,021277s038ltr.pdf 11/2/2010
AP011/24/2009SLR24174039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf 12/2/2009
AP011/24/2009SLR24612039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039ltr.pdf 1/25/2010
AP03/2/2010SLR24965040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf 3/5/2010
AP03/2/2010SLR25244040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s046,021277s040ltr.pdf 4/9/2010
AP02/25/2011SLR28016041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s047,021277s041ltr.pdf 3/2/2011
AP02/25/2011SLR28059041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf 3/4/2011
AP010/18/2011SLR30360046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf 10/20/2011
AP010/18/2011SLR30381046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf 10/20/2011
AP08/3/2011SLR29700049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s052,021277s049MedG.pdf 8/5/2011
AP08/3/2011SLR29720049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s052,021277s049ltr.pdf 8/8/2011
AP010/18/2011SLR30359050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf 10/20/2011
AP010/18/2011SLR30382050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf 10/20/2011
AP08/24/2012SLR33568052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s055,021277Orig1s052ltr.pdf 8/28/2012
AP08/24/2012SLR33697052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf 9/11/2012
AP012/18/2012SLR34739053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s056,021277s053lbl.pdf 12/21/2012
AP012/18/2012SLR34750053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s056,021277Orig1s053ltr.pdf 12/26/2012
AP08/14/2013SLR36796054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf 8/15/2013
AP08/14/2013SLR36828054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021277Orig1s054,021085Orig1s057ltr.pdf 8/16/2013
AP011/20/2014SLR41073055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021085Orig1s059,021277Orig1s055ltr.pdf 11/24/2014
AP011/20/2014SLR41145055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf 12/3/2014
AP05/8/2015SE842798056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021085Origs060,021277Orig1s056ltr.pdf 5/13/2015
AP05/8/2015SE843004056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf 6/5/2015
AP09/27/2016SE847205057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf 9/29/2016
AP09/27/2016SE847237057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf 9/30/2016
AP09/27/2016SLR47238058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf 9/30/2016
AP09/27/2016SLR47206058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf 9/29/2016
AP07/26/2016SLR46616059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf 7/26/2016
AP07/26/2016SLR46634059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021277Orig1s059,21085Orig1s063ltr.pdf 7/26/2016




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