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FDA Drug Application 021473 by BAYER HLTHCARE

Application Number021473
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
AP012/13/2002N3506000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21473ltr.pdf 12/13/2002
AP012/13/2002N3507000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21473_ciproXR_lbl.pdf 12/16/2002
AP012/13/2002N6893000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-473_Cipro.cfm 11/6/2003
AP012/13/2002N36826000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf 8/16/2013
AP012/13/2002N45096000ReviewApproval  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021473Orig1s000Approv.pdf 2/3/2016
AP07/14/2004SLR9764005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf 7/21/2004
AP07/14/2004SLR9819005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf 7/21/2004
AP07/14/2004SLR17233005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S005_CIPRO.pdf 7/9/2007
AP07/14/2004SLR9820006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf 7/21/2004
AP07/14/2004SLR9765006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf 7/21/2004
AP07/14/2004SLR17232006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S006_CIPRO.pdf 7/9/2007
AP07/14/2004SLR17231007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S007_CIPRO.pdf 7/9/2007
AP07/14/2004SLR9766007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21473s005,006,007ltr.pdf 7/21/2004
AP07/14/2004SLR9821007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21473s005,006,007lbl.pdf 7/21/2004
AP05/18/2005SLR11672009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021473s009ltr.pdf 5/20/2005
AP05/18/2005SLR11686009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021473s009lbl.pdf 5/20/2005
AP05/18/2005SLR17230009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S009_CIPRO.pdf 7/9/2007
AP011/9/2005SLR17229013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S013_CIPRO.pdf 7/9/2007
AP011/9/2005SLR13060013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf 11/17/2005
AP011/9/2005SLR13076013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf 11/18/2005
AP06/19/2006SLR       
AP06/25/2007SLR16850022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021473s022lbl.pdf 6/27/2007
AP06/25/2007SLR16887022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf 7/5/2007
AP01/18/2008SLR18923023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021473s023lbl.pdf 1/23/2008
AP01/18/2008SLR18932023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021473s023ltr.pdf 1/23/2008
AP010/3/2008SLR20962024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s049,020780s026,021473s024ltr.pdf 10/7/2008
AP010/3/2008SLR20995024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf 10/9/2008
AP04/27/2009SLR22454025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020780s028,021473s025ltr.pdf 5/7/2009
AP04/27/2009SLR22504025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf 5/11/2009
AP06/24/2009SLR22851026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf 6/30/2009
AP011/15/2011SLR30607027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s027lbl.pdf 11/16/2011
AP011/15/2011SLR30608027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s027MG.pdf 11/16/2011
AP011/15/2011SLR30664027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021473s027ltr.pdf 11/21/2011
AP02/25/2011SLR28013028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf 3/2/2011
AP02/25/2011SLR28065028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s028lbl.pdf 3/4/2011
AP06/10/2011SLR29123031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021473s031lbl.pdf 6/14/2011
AP06/10/2011SLR29142031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021473s031ltr.pdf 6/15/2011
AP08/3/2011SLR29702032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf 8/5/2011
AP08/3/2011SLR29718032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf 8/8/2011
AP010/18/2011SLR30365033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf 10/20/2011
AP010/18/2011SLR30511033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf 11/4/2011
AP010/18/2011SLR30520033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033MedG.pdf 11/4/2011
AP01/30/2013SLR35026034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021473Orig1s034ltr.pdf 1/31/2013
AP01/30/2013SLR35036034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s034lbl.pdf 2/1/2013
AP08/14/2013SLR36795035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021473s035lbl.pdf 8/15/2013
AP08/14/2013SLR36816035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021473Orig1s035ltr.pdf 8/16/2013
AP01/30/2015SLR41758036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021473Orig1s036ltr.pdf 2/2/2015
AP01/30/2015SLR41768036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021473s036lbl.pdf 2/3/2015
AP07/26/2016SLR46611037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021473s037lbl.pdf 7/26/2016
AP07/26/2016SLR46629037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf 7/26/2016




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