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FDA Drug Application 021078 by GLAXOSMITHKLINE

Application Number021078
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/14/2000N5911000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021078_malarone.cfm 6/16/2003
AP07/14/2000N5912000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Approv.pdf 6/16/2003
AP07/14/2000N5913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Prntlbl.pdf 6/16/2003
AP02/28/2002SLR3515001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078s001ltr.pdf 2/28/2002
AP02/28/2002SLR14436001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s001_MalaroneTOC.cfm 7/10/2006
AP09/3/2004SLR10137002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s002ltr.pdf 9/7/2004
AP09/3/2004SLR10138002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s002lbl.pdf 9/7/2004
AP08/2/2002SE814435003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s003_MalaroneTOC.cfm 7/10/2006
AP08/2/2002SE83513003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078se8-003ltr.pdf 8/2/2002
AP08/2/2002SE83514003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21078s3lbl.pdf 8/2/2002
AP05/13/2002SCS14431004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s004_MalaroneTOC.cfm 7/10/2006
AP05/9/2003S14432005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021078_s005_MalaroneTOC.cfm 7/10/2006
AP012/2/2003SE57057006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21078se5-006ltr.pdf 12/8/2003
AP012/2/2003SE57068006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21078se5-006_malarone_lbl.pdf 12/8/2003
AP011/24/2004SLR10678007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s007ltr.pdf 12/2/2004
AP011/24/2004SLR10715007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s007lbl.pdf 12/3/2004
AP02/27/2005SLR11197008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf 3/3/2005
AP02/27/2005SLR11205008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf 3/3/2005
AP02/27/2005SLR11206009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf 3/3/2005
AP02/27/2005SLR11198009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf 3/3/2005
AP012/4/2007SLR18861012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021078s012ltr.pdf 1/9/2008
AP05/7/2008SLR19797014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s014ltr.pdf 5/9/2008
AP05/7/2008SLR19986014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s014lbl.pdf 6/12/2008
AP012/18/2008SLR21416016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s016ltr.pdf 12/29/2008
AP012/18/2008SLR21451016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s016lbl.pdf 1/2/2009
AP09/2/2009SLR23754017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021078s017ltr.pdf 11/9/2009
AP02/27/2013SLR35297022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021078Orig1s022ltr.pdf 3/1/2013
AP02/27/2013SLR35316022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf 3/1/2013




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