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FDA Drug Application 021700 by SB PHARMCO

Application Number021700
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
AP011/23/2005N23885000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143421.pdf 11/16/2009
AP011/23/2005N13136000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021700lbl.pdf 11/30/2005
AP011/23/2005N13173000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021700ltr.pdf 11/30/2005
AP011/23/2005N16869000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021700s000TOC.cfm 7/2/2007
AP011/23/2005N19248000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm 2/21/2008
AP06/15/2006SLR14326002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf 6/20/2006
AP06/15/2006SLR14330002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf 6/20/2006
AP010/24/2006SE115203003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s003lbl.pdf 10/25/2006
AP010/24/2006SE115250003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s003ltr.pdf 10/26/2006
AP06/15/2006SLR14331004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf 6/20/2006
AP06/15/2006SLR14327004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf 6/20/2006
AP03/30/2007SCM16175005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s005ltr.pdf 4/9/2007
AP09/20/2007SLR17977006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s006ltr.pdf 9/25/2007
AP08/21/2007SLR17670007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021700s007lbl.pdf 8/22/2007
AP08/21/2007SLR17680007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s007ltr.pdf 8/22/2007
AP012/2/2008SLR21320008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021700s008ltr.pdf 12/4/2008
AP012/2/2008SLR21326008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf 12/4/2008
AP011/29/2009SLR24242009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021700s009lbl.pdf 12/10/2009
AP02/3/2011SLR27685010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf 2/3/2011
AP02/3/2011SLR27703010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf 2/4/2011
AP05/18/2011SLR28853011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf 5/17/2011
AP05/18/2011SLR28854011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011MedG.pdf 5/17/2011
AP05/18/2011SLR28915011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf 5/24/2011
AP011/13/2011SLR30626012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf 11/16/2011
AP011/13/2011SLR30627012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012MedG.pdf 11/16/2011
AP011/13/2011SLR30693012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf 11/21/2011
AP05/30/2012SLR32788013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf 6/4/2012
AP05/30/2012SLR32829013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021700s013lbl.pdf 6/6/2012
AP01/25/2013S35004015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf 1/30/2013
AP09/16/2013SLR37156016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf 9/19/2013
AP05/7/2014SLR39247018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf 5/8/2014
AP05/7/2014SLR39279018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf 5/12/2014
AP05/7/2014SLR39280019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf 5/12/2014
AP05/7/2014SLR39248019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf 5/8/2014
AP05/7/2014SLR39249020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf 5/8/2014
AP05/7/2014SLR39281020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf 5/12/2014
AP03/16/2015SLR42168021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021700Orig1s021ltr.pdf 3/17/2015
AP03/16/2015SLR42198021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf 3/19/2015
AP012/16/2015S44794022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf 12/17/2015




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