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FDA Drug Application 019537 by BAYER HLTHCARE

Application Number019537
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/1987N28246000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf 3/15/2011
AP02/24/1988SCE       
AP02/24/1988SCS       
AP010/12/1988SCS       
AP011/1/1988SCS       
AP010/25/1989SCS       
AP01/22/1993SLR       
AP011/19/1991SCM       
AP07/21/1994SE110313013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-537s015_Cipro.cfm 9/29/2004
AP07/21/1994SE110370015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-537s015_Cipro.cfm 10/8/2004
AP05/15/1997SE1       
AP09/10/1992SCS       
AP010/18/2011SLR       
AP09/13/1995SE1       
AP03/14/1994SCS       
AP09/11/1996SE1       
AP010/10/1996SE1       
AP09/26/1997SLR19608025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019537_S025_CIPRO.pdf 4/4/2008
AP04/8/1996SE1       
AP04/3/1998SE5       
AP011/22/1996SLR       
AP06/3/1997SE1       
AP09/17/1998SLR20553030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S030_CIPRO.pdf 8/11/2008
AP09/17/1998SLR20552031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S031_CIPRO.pdf 8/11/2008
AP011/18/1998SCP17221032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019537_S032_Cipro Tablets.pdf 7/9/2007
AP09/17/1998SLR20551033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S033_CIPRO.pdf 8/11/2008
AP06/28/2000SLR       
AP06/9/1999SCS17220035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019537_S035_Cipro Tablets.pdf 7/9/2007
AP06/28/2000SLR       
AP08/30/2000SE11535038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf 8/30/2000
AP08/30/2000SE11536038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf 8/30/2000
AP08/30/2000SE12433038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm 8/30/2000
AP06/28/2000SLR       
AP06/28/2000SLR       
AP04/17/2002SLR2423041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537s41ltr.pdf 4/17/2002
AP04/17/2002SLR2424041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf 4/17/2002
AP04/17/2002SLR19609041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S041_CIPRO.pdf 4/4/2008
AP012/4/2001SCM17219042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019537_S042_Cipro Tablets.pdf 7/9/2007
AP012/13/2002SCP3508043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537scp043ltr.pdf 12/16/2002
AP012/13/2002SCP18569043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S043_CIPPRO.pdf 11/19/2007
AP08/2/2002SCE19610044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S044_CIPRO.pdf 4/4/2008
AP012/10/2002SCM19611045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S045_CIPRO.pdf 4/4/2008
AP03/15/2004SLR8275048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf 4/5/2004
AP03/15/2004SLR8108048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf 3/28/2004
AP03/15/2004SLR18568048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S048_CIPRO.pdf 11/19/2007
AP03/25/2004SE58101049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf 3/28/2004
AP03/25/2004SE58281049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf 4/5/2004
AP03/25/2004SE519612049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm 4/4/2008
AP03/15/2004SLR18567050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S050_CIPRO.pdf 11/19/2007
AP03/15/2004SLR8276050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf 4/5/2004
AP03/15/2004SLR8109050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf 3/28/2004
AP03/15/2004SLR8110051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf 3/28/2004
AP03/15/2004SLR8277051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf 4/5/2004
AP03/15/2004SLR18566051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S051_CIPRO.pdf 11/19/2007
AP01/7/2005SE710931052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf 1/11/2005
AP01/7/2005SE710936052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf 1/11/2005
AP07/14/2004SLR19613053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S053_CIPRO.pdf 4/4/2008
AP07/14/2004SLR9791053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf 7/21/2004
AP07/14/2004SLR9801053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf 7/21/2004
AP07/14/2004SLR9802054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf 7/21/2004
AP07/14/2004SLR9792054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf 7/21/2004
AP07/14/2004SLR19614054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S054_CIPRO.pdf 4/4/2008
AP05/18/2005SLR11662057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s057,020780s019ltr.pdf 5/20/2005
AP05/18/2005SLR11695057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.pdf 5/20/2005
AP011/9/2005SLR13056060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf 11/17/2005
AP011/9/2005SLR13080060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf 11/18/2005
AP011/9/2005SLR17228060   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019537_S060_Cipro Tablets.pdf 7/9/2007
AP06/19/2006SLR14367062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf 6/28/2006
AP06/25/2007SLR16846065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019537s65lbl.pdf 6/27/2007
AP06/25/2007SLR16891065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf 7/5/2007
AP01/18/2008SLR18916067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s067,020780s025ltr.pdf 1/22/2008
AP01/18/2008SLR18919067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.pdf 1/23/2008
AP010/3/2008SLR20959068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s068,019847s042ltr.pdf 10/7/2008
AP010/3/2008SLR20999068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf 10/9/2008
AP010/3/2008SLR33768068   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019537Orig1s068.pdf 9/17/2012
AP02/13/2009SLR21852069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf 2/18/2009
AP02/13/2009SLR21877069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf 2/20/2009
AP04/27/2009SLR33769070   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019537Orig1s070.pdf 9/17/2012
AP04/27/2009SLR22450070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s070,019847s044ltr.pdf 5/7/2009
AP04/27/2009SLR22508070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf 5/11/2009
AP06/24/2009SLR22847071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf 6/30/2009
AP04/6/2009SLR22225073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s073,020780s030ltr.pdf 4/10/2009
AP04/6/2009SLR22270073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf 4/16/2009
AP011/15/2011SLR30613074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf 11/16/2011
AP011/15/2011SLR30616074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032MG.pdf 11/16/2011
AP011/15/2011SLR30657074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s074,020780s032ltr.pdf 11/21/2011
AP02/25/2011SLR28009075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf 3/2/2011
AP02/25/2011SLR28062075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf 3/4/2011
AP06/10/2011SLR29126078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf 6/14/2011
AP06/10/2011SLR29135078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036ltr.pdf 6/14/2011
AP08/3/2011SLR29705079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf 8/5/2011
AP08/3/2011SLR29714079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf 8/8/2011
AP010/18/2011SLR30361080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf 10/20/2011
AP010/18/2011SLR30515080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf 11/4/2011
AP010/18/2011SLR30516080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033MedG.pdf 11/4/2011
AP01/30/2013SLR35022081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s081,020780Orig1s039ltr.pdf 1/31/2013
AP01/30/2013SLR35040081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf 2/1/2013
AP08/14/2013SLR36792082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf 8/15/2013
AP08/14/2013SLR36823082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s082,020780Orig1s040ltr.pdf 8/16/2013
AP02/2/2015SE141824083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf 2/12/2015
AP02/2/2015SE141957083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf 3/2/2015
AP011/21/2014SCM       
AP09/14/2016SLR47058085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf 9/15/2016
AP09/14/2016SLR47077085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537Orig1s085,020780Orig1s042ltr.pdf 9/19/2016
AP07/26/2016SLR46615086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s086lbl.pdf 7/26/2016
AP07/26/2016SLR46625086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf 7/26/2016




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