Back to FDA Applications sponsored by BAYER HLTHCARE

FDA Drug Application 020780 by BAYER HLTHCARE

Application Number020780
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
AP09/26/1997N28248000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246794.pdf 3/15/2011
AP09/17/1998SLR20540001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S001_Cipro.pdf 8/8/2008
AP09/17/1998SLR20539002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S002_CIPRO.pdf 8/8/2008
AP09/17/1998SLR20538003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020780_S003_Cipro.pdf 8/8/2008
AP09/17/1998SLR       
AP03/5/1999SLR       
AP06/28/2000SLR       
AP06/28/2000SLR       
AP08/30/2000SE12443008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf 8/30/2000
AP08/30/2000SE12444008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf 8/30/2000
AP08/30/2000SE12445008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm 8/30/2000
AP06/28/2000SLR       
AP06/28/2000SLR       
AP04/17/2002SLR2425011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537s41ltr.pdf 4/17/2002
AP04/17/2002SLR2426011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf 4/17/2002
AP04/17/2002SLR20438011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020780_S011_CIPRO.pdf 8/1/2008
AP03/15/2004SLR18517012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S012_CIPRO.pdf 11/19/2007
AP03/15/2004SLR8278012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf 4/5/2004
AP03/15/2004SLR8105012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf 3/28/2004
AP03/25/2004SE58104013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf 3/28/2004
AP03/25/2004SE58284013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf 4/5/2004
AP03/25/2004SE520371013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm 7/31/2008
AP03/15/2004SLR18516014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S014_CIPRO.pdf 11/19/2007
AP03/15/2004SLR8279014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf 4/5/2004
AP03/15/2004SLR8106014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf 3/28/2004
AP03/15/2004SLR8107015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf 3/28/2004
AP03/15/2004SLR8280015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf 4/5/2004
AP03/15/2004SLR18515015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S015_CIPRO.pdf 11/19/2007
AP01/7/2005SE710934016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf 1/11/2005
AP01/7/2005SE710939016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf 1/11/2005
AP07/14/2004SLR9803017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf 7/21/2004
AP07/14/2004SLR9793017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf 7/21/2004
AP07/14/2004SLR20370017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S017_CIPRO.pdf 7/31/2008
AP07/14/2004SLR20369018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S018_CIPRO.pdf 7/31/2008
AP07/14/2004SLR9794018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf 7/21/2004
AP07/14/2004SLR9804018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf 7/21/2004
AP05/18/2005SLR11661019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s057,020780s019ltr.pdf 5/20/2005
AP05/18/2005SLR11694019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.pdf 5/20/2005
AP011/9/2005SLR13059020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf 11/17/2005
AP011/9/2005SLR13077020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf 11/18/2005
AP011/9/2005SLR17225020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020780_S020_CIPRO.pdf 7/9/2007
AP06/19/2006SLR14368023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf 6/28/2006
AP06/25/2007SLR16849024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020780s24lbl.pdf 6/27/2007
AP06/25/2007SLR16888024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf 7/5/2007
AP01/18/2008SLR18917025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s067,020780s025ltr.pdf 1/22/2008
AP01/18/2008SLR18918025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.pdf 1/23/2008
AP010/3/2008SLR20961026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019857s049,020780s026,021473s024ltr.pdf 10/7/2008
AP010/3/2008SLR20996026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf 10/9/2008
AP02/13/2009SLR21855027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf 2/18/2009
AP02/13/2009SLR21884027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf 2/20/2009
AP04/27/2009SLR22453028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020780s028,021473s025ltr.pdf 5/7/2009
AP04/27/2009SLR22507028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf 5/11/2009
AP06/24/2009SLR22850029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf 6/30/2009
AP04/6/2009SLR22226030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s073,020780s030ltr.pdf 4/10/2009
AP04/6/2009SLR22269030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf 4/16/2009
AP011/15/2011SLR30614032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf 11/16/2011
AP011/15/2011SLR30615032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032MG.pdf 11/16/2011
AP011/15/2011SLR30658032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s074,020780s032ltr.pdf 11/21/2011
AP02/25/2011SLR28012033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf 3/2/2011
AP02/25/2011SLR28061033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf 3/4/2011
AP06/10/2011SLR29125036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf 6/14/2011
AP06/10/2011SLR29136036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036ltr.pdf 6/14/2011
AP08/3/2011SLR29703037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s079,019847s051,019857s058,020780s037,021473s032MedG.pdf 8/5/2011
AP08/3/2011SLR29717037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf 8/8/2011
AP010/18/2011SLR30364038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf 10/20/2011
AP010/18/2011SLR30512038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf 11/4/2011
AP010/18/2011SLR30519038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033MedG.pdf 11/4/2011
AP01/30/2013SLR35023039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s081,020780Orig1s039ltr.pdf 1/31/2013
AP01/30/2013SLR35039039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf 2/1/2013
AP08/14/2013SLR36791040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf 8/15/2013
AP08/14/2013SLR36824040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s082,020780Orig1s040ltr.pdf 8/16/2013
AP02/2/2015SE841827041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf 2/12/2015
AP02/2/2015SE841956041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf 3/2/2015
AP09/14/2016SLR47059042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf 9/15/2016
AP09/14/2016SLR47078042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537Orig1s085,020780Orig1s042ltr.pdf 9/19/2016
AP07/26/2016SLR46612043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf 7/26/2016
AP07/26/2016SLR46628043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf 7/26/2016




Back to FDA Applications sponsored by BAYER HLTHCARE

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.