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FDA Drug Application 021085 by BAYER HLTHCARE

Application Number021085
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
AP012/10/1999N1146000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21085ltr.pdf 12/10/1999
AP012/10/1999N1147000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21085lbl.pdf 12/10/1999
AP012/10/1999N8780000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-085_Avelox.cfm 5/27/2004
AP012/10/1999N34823000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231731.pdf 1/3/2013
AP05/4/2000SLR       
AP04/21/2000SCM       
AP05/17/2001SLR       
AP05/17/2001SLR       
AP06/12/2002SLR4586006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf 6/12/2002
AP06/12/2002SLR4587006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf 6/12/2002
AP06/12/2002SLR4588007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21085s006ltr.pdf 6/12/2002
AP06/12/2002SLR4589007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s6s7lbl.pdf 6/12/2002
AP02/2/2001SCS       
AP04/27/2001SLR4599010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_Approv.pdf 4/27/2001
AP04/27/2001SLR4600010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_prntlbl.pdf 4/27/2001
AP04/27/2001SLR8784010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S10_Avelox.cfm 5/27/2004
AP05/16/2002SLR4592012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21-085s012ltr.pdf 5/16/2002
AP05/16/2002SLR4593012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21085s12lbl.pdf 5/16/2002
AP012/10/2002SCS       
AP02/28/2003SLR3857014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf 2/28/2003
AP02/28/2003SLR4243014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 3/10/2003
AP02/28/2003SE14244015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 3/10/2003
AP02/28/2003SE13858015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf 2/28/2003
AP02/28/2003SLR3859017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021085s014lbl.pdf 2/28/2003
AP02/28/2003SLR4245017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 3/10/2003
AP010/6/2003SLR6763019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr019ltr.pdf 10/6/2003
AP010/6/2003SLR6784019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21277slr011,21085slr019_avelox_lbl.pdf 10/10/2003
AP05/18/2004SE18641022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-022,21277se1-017ltr.pdf 5/26/2004
AP05/18/2004SE18712022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21085se1-022,21277se1-017_avelox_lbl.pdf 5/27/2004
AP05/18/2004SE119143022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021085_S022_Avelox_Tablets.pdf 2/19/2008
AP03/6/2004SLR7847023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277slr018,21085slr023ltr.pdf 3/10/2004
AP03/6/2004SLR8228023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277slr018,21085slr023_avelox_lbl.pdf 4/5/2004
AP07/28/2004SLR9913024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21277s019,21085s024ltr.pdf 7/30/2004
AP07/28/2004SLR9922024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21277s019,21085s024lbl.pdf 7/30/2004
AP012/14/2004SCS       
AP06/13/2005SE111802026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022ltr.pdf 6/14/2005
AP06/13/2005SE111811026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s026,021277s022lbl.pdf 6/14/2005
AP011/22/2005SE113145027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf 11/30/2005
AP011/22/2005SE113165027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf 11/30/2005
AP011/22/2005SLR13166029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf 11/30/2005
AP011/22/2005SLR13146029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021085s027,029,021277s024,025lbl.pdf 11/30/2005
AP05/31/2007SLR16672036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021085s036,021277s030ltr.pdf 6/4/2007
AP05/31/2007SLR16689036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021085s036,021277s030lbl.pdf 6/4/2007
AP02/15/2008SLR19241038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s038ltr.pdf 2/20/2008
AP02/15/2008SLR19270038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s038,021277s031lbl.pdf 2/25/2008
AP012/29/2008SLR21433039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039, 021277s033ltr.pdf 12/31/2008
AP012/29/2008SLR21464039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s039,021277s033lbl.pdf 1/2/2009
AP010/3/2008SLR20968040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s040, 021277s034ltr.pdf 10/7/2008
AP010/3/2008SLR21002040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021085s040,021277s034lbl.pdf 10/9/2008
AP06/24/2009SLR22833041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s041,021277s035ltr.pdf 6/29/2009
AP04/27/2009SLR22422042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036ltr.pdf 5/5/2009
AP04/27/2009SLR22584042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s042,021277s036lbl.pdf 5/15/2009
AP010/25/2010SLR26780044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s044lbl.pdf 10/25/2010
AP010/25/2010SLR26856044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s044,021277s038ltr.pdf 11/2/2010
AP011/23/2009SLR24173045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021085s045,021277s039lbl.pdf 12/2/2009
AP011/23/2009SLR24611045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039ltr.pdf 1/25/2010
AP03/2/2010SLR24964046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021085s046,021277s040lbl.pdf 3/5/2010
AP03/2/2010SLR25243046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021085s046,021277s040ltr.pdf 4/9/2010
AP02/25/2011SLR28015047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s047,021277s041ltr.pdf 3/2/2011
AP02/25/2011SLR28060047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf 3/4/2011
AP010/18/2011SLR30383050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf 10/20/2011
AP010/18/2011SLR30357050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf 10/20/2011
AP08/3/2011SLR29701052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s052,021277s049MedG.pdf 8/5/2011
AP08/3/2011SLR29719052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s052,021277s049ltr.pdf 8/8/2011
AP010/18/2011SLR30384053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s050s053,021277s046s050lbl.pdf 10/20/2011
AP010/18/2011SLR30358053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021085s050,s053,021277s046,s050ltr.pdf 10/20/2011
AP08/24/2012SLR33567055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s055,021277Orig1s052ltr.pdf 8/28/2012
AP08/24/2012SLR33696055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s55-021277s052lbl.pdf 9/11/2012
AP012/18/2012SLR34738056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021085s056,021277s053lbl.pdf 12/21/2012
AP012/18/2012SLR34749056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021085Orig1s056,021277Orig1s053ltr.pdf 12/26/2012
AP08/14/2013SLR36797057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021085s057,021277s054lbl.pdf 8/15/2013
AP08/14/2013SLR36829057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021277Orig1s054,021085Orig1s057ltr.pdf 8/16/2013
AP011/19/2014SCM       
AP011/20/2014SLR41072059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021085Orig1s059,021277Orig1s055ltr.pdf 11/24/2014
AP011/20/2014SLR41144059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021085s059,021277s055lbl.pdf 12/3/2014
AP05/8/2015SE842799060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021085Origs060,021277Orig1s056ltr.pdf 5/13/2015
AP05/8/2015SE843005060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021085s060,021277s056lbl.pdf 6/5/2015
AP09/27/2016SE847207061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf 9/29/2016
AP09/27/2016SE847235061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf 9/30/2016
AP09/27/2016SLR47236062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021085Orig1s061,s062,021277Orig1s057,s058ltr.pdf 9/30/2016
AP09/27/2016SLR47208062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021085s061s062,021277s057s058lbl.pdf 9/29/2016
AP07/26/2016SLR46617063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021277Orig1s059,21085Orig1s063lbledt.pdf 7/26/2016
AP07/26/2016SLR46639063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021277Orig1s059,21085Orig1s063ltr.pdf 7/26/2016




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