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FDA Drug Application 021410 by SB PHARMCO

Application Number021410
Application Type New Drug Application
Sponsor ApplicantSB PHARMCO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/10/2002N4578000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21410ltr.pdf 5/9/2000
AP010/10/2002N4579000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21410lbl.pdf 10/10/2002
AP010/10/2002N5528000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021410_avandamet.cfm 4/30/2003
AP010/10/2002N19247000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm 2/21/2008
AP010/10/2002N23884000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143419.pdf 11/16/2009
AP08/25/2003SCF6573001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21410scf001ltr.pdf 8/28/2003
AP08/25/2003SCF6574001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21410scf001_avandamet_lbl.pdf 8/28/2003
AP05/19/2004SLR8644005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf 5/26/2004
AP05/19/2004SLR8709005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf 5/27/2004
AP05/19/2004SLR8645006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf 5/26/2004
AP05/19/2004SLR8710006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21071slr009,21410slr005,006_avandamet_lbl.pdf 5/27/2004
AP01/4/2005SLR10946009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21410s009lbl.pdf 1/11/2005
AP01/4/2005SLR11177009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s014,21410s009ltr.pdf 3/1/2005
AP01/4/2005SLR23286009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021071_s014_Avandia%20Tabs.pdf 9/14/2009
AP05/19/2006SE114149010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s010lbl.pdf 5/22/2006
AP05/19/2006SE114154010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021410s010LTR.pdf 5/22/2006
AP04/19/2006SLR13953013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021410s013lbl.pdf 4/20/2006
AP04/19/2006SLR13973013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021410s013LTR.pdf 4/21/2006
AP01/31/2007SE115740016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s016lbl.pdf 2/2/2007
AP01/31/2007SE115790016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s016ltr.pdf 2/12/2007
AP04/23/2007SLR16286019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s019lbl.pdf 4/25/2007
AP04/23/2007SLR16417019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s019ltr.pdf 5/1/2007
AP09/20/2007SLR17972022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s022ltr.pdf 9/25/2007
AP09/20/2007SLR18023022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s022lbl.pdf 9/26/2007
AP08/21/2007SLR17669023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021410s023lbl.pdf 8/22/2007
AP08/21/2007SLR17681023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021410s023ltr.pdf 8/22/2007
AP012/2/2008SLR21318025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021410s025ltr.pdf 12/4/2008
AP012/2/2008SLR21327025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021410s025lbl.pdf 12/4/2008
AP02/3/2011SLR27686026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf 2/3/2011
AP02/3/2011SLR27702026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf 2/4/2011
AP05/18/2011SLR28851027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s027lbl.pdf 5/17/2011
AP05/18/2011SLR28852027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s027MedG.pdf 5/17/2011
AP05/18/2011SLR28914027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf 5/24/2011
AP011/13/2011SLR30624029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s029MedG.pdf 11/16/2011
AP011/13/2011SLR30625029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021410s029lbl.pdf 11/16/2011
AP011/13/2011SLR30692029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf 11/21/2011
AP05/30/2012SLR32787030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf 6/4/2012
AP05/30/2012SLR32828030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021410s030lbl.pdf 6/6/2012
AP01/25/2013S35003032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf 1/30/2013
AP06/11/2013SCM       
AP09/16/2013SLR37155034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf 9/19/2013
AP05/7/2014SLR39254036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf 5/8/2014
AP05/7/2014SLR39276036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf 5/12/2014
AP05/7/2014SLR39255037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf 5/8/2014
AP05/7/2014SLR39277037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf 5/12/2014
AP05/7/2014SLR39256038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021410Orig1s036,s037,s038ltr.pdf 5/8/2014
AP05/7/2014SLR39278038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021410s036s037s038lbl.pdf 5/12/2014
AP012/16/2015S44796039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf 12/17/2015




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