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FDA Drug Application 019857 by BAYER HLTHCARE

Application Number019857
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
AP012/26/1990N36825000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf 8/16/2013
AP04/24/1991SCP       
AP04/24/1991SCP       
AP05/13/1992SCS       
AP04/23/1992SCS       
AP010/25/1995SLR       
AP010/21/1996SE1       
AP012/27/1993SCS       
AP04/28/1994SCS       
AP010/10/1996SE1       
AP09/26/1997SLR20562013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019857_S013_CIPRO.pdf 8/11/2008
AP04/3/1998SE5       
AP06/28/1996SCP       
AP08/9/1996SLR       
AP08/7/1997SE1       
AP08/15/1997SCM       
AP09/24/1998SE1       
AP09/24/1998SLR       
AP09/24/1998SE1       
AP011/13/1998SCS       
AP01/7/1999SCM       
AP09/24/1998SLR       
AP06/28/2000SLR       
AP06/9/1999SCS       
AP08/30/2000SE12434027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf 8/30/2000
AP08/30/2000SE12435027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf 8/30/2000
AP08/30/2000SE12436027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm 8/30/2000
AP04/17/2002SLR2429028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf 4/17/2002
AP04/17/2002SLR2430028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf 4/17/2002
AP04/17/2002SLR20447028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019857_S028_CIPRO.pdf 8/4/2008
AP012/10/2002SCM       
AP03/25/2004SE58102031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf 3/28/2004
AP03/25/2004SE58282031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf 4/5/2004
AP03/25/2004SE520384031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm 7/31/2008
AP07/14/2004SLR9788033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf 7/21/2004
AP07/14/2004SLR9808033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf 7/21/2004
AP07/14/2004SLR20383033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019857_S033_CIPRO.pdf 7/31/2008
AP07/14/2004SLR9789034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf 7/21/2004
AP07/14/2004SLR9809034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf 7/21/2004
AP07/14/2004SLR20382034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019857_S034_CIPRO.pdf 7/31/2008
AP01/7/2005SE710933035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf 1/11/2005
AP01/7/2005SE710938035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf 1/11/2005
AP07/14/2004SLR9790036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf 7/21/2004
AP07/14/2004SLR9810036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf 7/21/2004
AP07/14/2004SLR20381036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019857_S036_CIPRO.pdf 7/31/2008
AP05/18/2005SLR11666038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019847s032,019857s038ltr.pdf 5/20/2005
AP05/18/2005SLR11691038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf 5/20/2005
AP011/9/2005SLR13058041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf 11/17/2005
AP011/9/2005SLR13078041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf 11/18/2005
AP011/9/2005SLR17226041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019857_S041_Cipro.pdf 7/9/2007
AP06/19/2006SLR14370042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf 6/28/2006
AP06/25/2007SLR16848046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019857s46lbl.pdf 6/27/2007
AP06/25/2007SLR16889046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf 7/5/2007
AP01/18/2008SLR18920048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf 1/23/2008
AP01/18/2008SLR18944048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s048ltr.pdf 1/24/2008
AP010/3/2008SLR20997049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf 10/9/2008
AP02/13/2009SLR21854050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf 2/18/2009
AP02/13/2009SLR21881050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf 2/20/2009
AP02/13/2009SLR21882050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27CiproMedG.pdf 2/20/2009
AP04/27/2009SLR22452051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019857s051ltr.pdf 5/7/2009
AP04/27/2009SLR22513051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf 5/11/2009
AP06/24/2009SLR22849052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf 6/30/2009
AP011/15/2011SLR30610053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf 11/16/2011
AP011/15/2011SLR30611053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053MG.pdf 11/16/2011
AP011/15/2011SLR30660053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s046,019857s053ltr.pdf 11/21/2011
AP02/25/2011SLR28011054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf 3/2/2011
AP02/25/2011SLR28063054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf 3/4/2011
AP08/12/2011SLR29785057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s050,019857s057ltr.pdf 8/15/2011
AP08/12/2011SLR29795057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057MedG.pdf 8/16/2011
AP08/12/2011SLR29796057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf 8/16/2011
AP08/3/2011SLR29716058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf 8/8/2011
AP08/3/2011SLR29779058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf 8/12/2011
AP010/18/2011SLR30363059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf 10/20/2011
AP010/18/2011SLR30513059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf 11/4/2011
AP010/18/2011SLR30518059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033MedG.pdf 11/4/2011
AP01/30/2013SLR35025060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s053,019857Orig1s060ltr.pdf 1/31/2013
AP01/30/2013SLR35037060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf 2/1/2013
AP010/14/2013SCM       
AP08/14/2013SLR36794062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019857s062lbl.pdf 8/15/2013
AP08/14/2013SLR36821062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019857Orig1s062ltr.pdf 8/16/2013
AP02/2/2015SE841826063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf 2/12/2015
AP02/2/2015SE841958063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf 3/2/2015
AP03/19/2015SLR42218064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019847Orig1s056,019857Orig1s064ltr.pdf 3/20/2015
AP03/19/2015SLR42226064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf 3/20/2015
AP07/26/2016SLR46613065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019857s065lbl.pdf 7/26/2016
AP07/26/2016SLR46627065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf 7/26/2016




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