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FDA Drug Application 020802 by GLAXOSMITHKLINE CONS

Application Number020802
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CONS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/14/1998N11978000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020802_s000_ExcedrinTOC.cfm 7/13/2005
AP010/22/1998SCM       
AP010/7/1999SE11171002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20802s02ltr.pdf 10/7/1999
AP010/7/1999SE11172002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20802s02lbl.pdf 10/7/1999
AP010/7/1999SE11831002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-802s002_Excedrin.cfm 10/7/1999
AP08/20/1999SCM       
AP09/7/2000SLR       
AP04/26/2000SCS       
AP010/10/2000SCM       
AP04/19/2002SCM       
AP05/21/2003SLR5832009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20802slr009ltr.pdf 6/8/2003
AP05/21/2003SLR5888009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20802slr009_excedrin_lbl.pdf 6/8/2003
AP08/27/2004SCP10099010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20802s010ltr.pdf 8/31/2004
AP01/31/2007SLR15787015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020802s015ltr.pdf 2/12/2007
AP02/4/2010SLR24794019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020802s019ltr.pdf 2/17/2010
AP04/15/2014SLR39084022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s022ltr.pdf 4/17/2014
AP04/15/2014SLR39116022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802s022.pdf 4/22/2014
AP07/15/2014SLR39894024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020802Orig1s024ltr.pdf 7/17/2014
AP07/15/2014SLR40068024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020802Orig1s024lbl.pdf 7/30/2014
AP07/30/2014SCM       
AP011/17/2015SCM       
AP01/28/2016SCM       
AP04/29/2016SCM       




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