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FDA Drug Application 021071 by SB PHARMCO

Application Number021071
Application Type New Drug Application
Sponsor ApplicantSB PHARMCO
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
AP05/25/1999N1122000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21071ltr.pdf 5/25/1999
AP05/25/1999N1123000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21071lbl.pdf 5/25/1999
AP05/25/1999N8775000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21071_Avandia.cfm 5/27/2004
AP05/25/1999N19246000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm 2/21/2008
AP05/25/1999N19292000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085922.pdf 2/25/2008
AP04/3/2000SE14581001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21071S1LTR.PDF 4/4/2000
AP04/3/2000SE14582001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.pdf 4/4/2000
AP04/3/2000SE18774001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia.cfm 5/27/2004
AP07/11/2000SLR       
AP07/3/2000SCM       
AP02/27/2003SE13740004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf 2/27/2003
AP02/27/2003SE14263004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21071se1-004ltr.pdf 3/10/2003
AP02/27/2003SE117403004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021071_S004_AVANDIA.pdf 7/27/2007
AP012/5/2000SLR       
AP02/8/2001SLR       
AP012/13/2000SCS       
AP012/3/2002SLR4580008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21071slr008ltr.pdf 12/3/2002
AP05/19/2004SLR8643009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf 5/26/2004
AP05/12/2005SLR11612010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s010ltr.pdf 5/17/2005
AP05/12/2005SLR11640010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf 5/17/2005
AP02/28/2005SE111191012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s012ltr.pdf 3/3/2005
AP02/28/2005SE111202012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf 3/3/2005
AP01/4/2005SLR10925014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s014,21410s009ltr.pdf 1/11/2005
AP01/4/2005SLR10945014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf 1/11/2005
AP01/4/2005SLR23285014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021071_s014_Avandia Tabs.pdf 9/14/2009
AP07/29/2005SE512503015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s015ltr.pdf 8/3/2005
AP07/29/2005SE512514015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf 8/3/2005
AP04/21/2006SE813981016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s016lbl.pdf 4/25/2006
AP04/21/2006SE813989016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s016LTR.pdf 4/25/2006
AP06/16/2006SLR14322019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf 6/20/2006
AP06/16/2006SLR14333019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf 6/20/2006
AP06/16/2006SLR14323021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf 6/20/2006
AP06/16/2006SLR14334021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf 6/20/2006
AP04/23/2007SLR16290023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s023lbl.pdf 4/25/2007
AP04/23/2007SLR16418023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s023ltr.pdf 5/1/2007
AP06/25/2007SLR       
AP07/10/2008SE820190026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf 7/14/2008
AP07/10/2008SE820202026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s026ltr.pdf 7/14/2008
AP09/20/2007SLR17968027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s027ltr.pdf 9/25/2007
AP09/20/2007SLR18022027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf 9/26/2007
AP08/14/2007SLR17626028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf 8/15/2007
AP08/14/2007SLR17654028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s028LTR.pdf 8/17/2007
AP01/16/2008SLR18891029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s029lbl.pdf 1/18/2008
AP01/16/2008SLR18901029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s029ltr.pdf 1/18/2008
AP011/14/2007SLR18418031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf 11/19/2007
AP011/14/2007SLR18458031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s031ltr.pdf 11/19/2007
AP02/22/2008SLR19268032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s032lbl.pdf 2/25/2008
AP02/22/2008SLR19294032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s032ltr.pdf 2/25/2008
AP010/20/2008SLR21037034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s034ltr.pdf 10/21/2008
AP010/20/2008SLR21116034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf 10/31/2008
AP02/3/2011SLR27687038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf 2/3/2011
AP02/3/2011SLR27704038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf 2/4/2011
AP05/18/2011SLR28849039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039lbl.pdf 5/17/2011
AP05/18/2011SLR28850039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039MedG.pdf 5/17/2011
AP05/18/2011SLR28913039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf 5/24/2011
AP011/13/2011SLR30622040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040lbl.pdf 11/16/2011
AP011/13/2011SLR30623040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040MedG.pdf 11/16/2011
AP011/13/2011SLR30691040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf 11/21/2011
AP05/30/2012SLR32786041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf 6/4/2012
AP05/30/2012SLR32827041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf 6/6/2012
AP01/25/2013SLR35002044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf 1/30/2013
AP09/16/2013SLR37154045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf 9/19/2013
AP05/7/2014SLR39251047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf 5/8/2014
AP05/7/2014SLR39273047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf 5/12/2014
AP05/7/2014SLR39252048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf 5/8/2014
AP05/7/2014SLR39274048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf 5/12/2014
AP05/7/2014SLR46724048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021071Orig1s048.pdf 8/4/2016
AP05/7/2014SLR39253049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf 5/8/2014
AP05/7/2014SLR39275049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf 5/12/2014
AP012/16/2015S44795050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf 12/17/2015
AP09/19/2016SLR47132051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021071Orig1s051ltr.pdf 9/21/2016
AP09/19/2016SLR47143051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf 9/21/2016




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