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FDA Drug Application 020941 by GLAXOSMITHKLINE

Application Number020941
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/25/2000N663000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20941ltr.pdf 7/25/2000
AP07/25/2000N664000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20941lbl.pdf 7/25/2000
AP07/25/2000N4690000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-941_Abreva.cfm 8/21/2001
AP03/12/2001SCM       
AP09/18/2001SCE       
AP012/13/2002SCS       
AP05/23/2007SCP16595006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020941s006ltr.pdf 5/29/2007
AP05/23/2007SCP16638006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020941s006lbl.pdf 5/29/2007
AP02/8/2008SCM19091009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020941s009ltr.pdf 2/14/2008
AP01/30/2015SLR41757011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020941Orig1s011ltr.pdf 2/2/2015
AP01/30/2015SLR41863011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020941Orig1s011lbl.pdf 2/17/2015




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