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FDA Drug Application 019847 by BAYER HLTHCARE

Application Number019847
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
AP012/26/1990N28247000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf 3/15/2011
AP05/13/1992SCS       
AP05/13/1992SCS       
AP04/23/1992SCS       
AP010/25/1995SLR       
AP02/12/1993SCM       
AP010/21/1996SE1       
AP06/14/1993SCE       
AP010/10/1996SE1       
AP09/26/1997SLR20563012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019847_S012_CIPRO.pdf 8/11/2008
AP04/3/1998SE5       
AP08/9/1996SLR       
AP08/7/1997SE1       
AP09/24/1998SE1       
AP09/24/1998SLR       
AP09/24/1998SE1       
AP09/24/1998SLR       
AP06/28/2000SLR       
AP011/1/1999SCM20533022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019847_S022_CIPRO.pdf 8/8/2008
AP08/30/2000SE12437024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf 8/30/2000
AP08/30/2000SE12438024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf 8/30/2000
AP08/30/2000SE12439024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm 8/30/2000
AP010/31/2000SCM       
AP04/17/2002SLR20450026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019847_S026_CIPRO.pdf 8/4/2008
AP04/17/2002SLR2427026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf 4/17/2002
AP04/17/2002SLR2428026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf 4/17/2002
AP03/25/2004SE58103027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf 3/28/2004
AP03/25/2004SE58283027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf 4/5/2004
AP03/25/2004SE520388027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm 7/31/2008
AP07/14/2004SLR20387028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S028_CIPRO.pdf 7/31/2008
AP07/14/2004SLR9785028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf 7/21/2004
AP07/14/2004SLR9805028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf 7/21/2004
AP07/14/2004SLR9806029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf 7/21/2004
AP07/14/2004SLR20386029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S029_CIPRO.pdf 7/31/2008
AP07/14/2004SLR9786029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf 7/21/2004
AP01/7/2005SE710932030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf 1/11/2005
AP01/7/2005SE710937030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf 1/11/2005
AP07/14/2004SLR9787031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19847s028,029,031,19857s033,034,036ltr.pdf 7/21/2004
AP07/14/2004SLR20385031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019847_S031_CIPRO.pdf 7/31/2008
AP07/14/2004SLR9807031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19847s028,029,031,19857s033,034,036lbl.pdf 7/21/2004
AP05/18/2005SLR11667032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019847s032,019857s038ltr.pdf 5/20/2005
AP05/18/2005SLR11692032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019847s032,019857s038lbl.pdf 5/20/2005
AP011/9/2005SLR13057036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf 11/17/2005
AP011/9/2005SLR13079036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf 11/18/2005
AP011/9/2005SLR17227036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019847_S036_Cipro.pdf 7/9/2007
AP06/19/2006SLR14369037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf 6/28/2006
AP06/25/2007SLR16847039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019847s39lbl.pdf 6/27/2007
AP06/25/2007SLR16890039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf 7/5/2007
AP01/18/2008SLR18921041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019847s041,019857s048lbl.pdf 1/23/2008
AP01/18/2008SLR18946041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019847s041ltr.pdf 1/24/2008
AP010/3/2008SLR20960042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s068,019847s042ltr.pdf 10/7/2008
AP010/3/2008SLR20998042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf 10/9/2008
AP02/13/2009SLR21853043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf 2/18/2009
AP02/13/2009SLR21880043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf 2/20/2009
AP04/27/2009SLR22451044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s070,019847s044ltr.pdf 5/7/2009
AP04/27/2009SLR22510044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf 5/11/2009
AP06/24/2009SLR22848045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf 6/30/2009
AP011/15/2011SLR30609046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053lbl.pdf 11/16/2011
AP011/15/2011SLR30612046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s046,019857s053MG.pdf 11/16/2011
AP011/15/2011SLR30659046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s046,019857s053ltr.pdf 11/21/2011
AP02/25/2011SLR28010047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf 3/2/2011
AP02/25/2011SLR28064047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s047,019857s054lbl.pdf 3/4/2011
AP08/12/2011SLR29784050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019847s050,019857s057ltr.pdf 8/15/2011
AP08/12/2011SLR29793050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057lbl.pdf 8/16/2011
AP08/12/2011SLR29794050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019847s050,019857s057MedG.pdf 8/16/2011
AP08/3/2011SLR29704051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf 8/5/2011
AP08/3/2011SLR29715051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf 8/8/2011
AP010/18/2011SLR30362052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf 10/20/2011
AP010/18/2011SLR30514052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf 11/4/2011
AP010/18/2011SLR30517052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033MedG.pdf 11/4/2011
AP01/30/2013SLR35024053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s053,019857Orig1s060ltr.pdf 1/31/2013
AP01/30/2013SLR35038053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s053,019857s060lbl.pdf 2/1/2013
AP08/14/2013SLR36793054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019847s054lbl.pdf 8/15/2013
AP08/14/2013SLR36822054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019847Orig1s054ltr.pdf 8/16/2013
AP02/2/2015SE841825055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf 2/12/2015
AP02/2/2015SE841959055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s055,019857s063lbl.pdf 3/2/2015
AP03/19/2015SLR42217056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019847Orig1s056,019857Orig1s064ltr.pdf 3/20/2015
AP03/19/2015SLR42227056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019847s056,019857s064lbl.pdf 3/20/2015
AP07/26/2016SLR46614057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019847s057lbl.pdf 7/26/2016
AP07/26/2016SLR46626057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf 7/26/2016




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