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FDA Drug Application 020403 by GLAXOSMITHKLINE

Application Number020403
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP01/31/1995N       
AP05/24/1996SLR       
AP07/26/1996SCP       
AP03/12/1996SLR       
AP04/2/1997SLR       
AP010/31/1997SLR4360005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-007s022_Zofran.cfm 10/31/1997
AP03/10/1999SLR       
AP02/17/1999SLR       
AP04/11/2000SLR21625009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020403_s009_ZOFRAN_INJECTION.pdf 1/12/2009
AP012/8/2000SLR       
AP012/8/2000SLR       
AP011/15/2000SCS       
AP011/24/2004SLR10696013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20007s034,20403s013ltr.pdf 12/2/2004
AP011/24/2004SLR10700013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20007s034,20403s013lbl.pdf 12/3/2004
AP012/27/2005SLR13330014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020007s037,020403s014lbl.pdf 1/5/2006
AP012/27/2005SLR13362014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020403s014rev2.pdf 1/6/2006
AP012/27/2005SLR23340014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020403_s014_Zofran Inj.pdf 9/16/2009
AP08/22/2006SLR14749016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020007s039,020403s016lbl.pdf 8/23/2006
AP08/22/2006SLR14886016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020007s039;020403s016ltr.pdf 9/18/2006
AP09/22/2010SLR26550018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020007s040,020403s018ltr.pdf 9/28/2010
AP09/22/2010SLR26575018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf 9/29/2010
AP07/7/2011SLR29488019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s041,020403s019lbl.pdf 7/12/2011
AP07/7/2011SLR29507019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s041,020403s019ltr.pdf 7/13/2011
AP09/14/2011SLR29990020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020007s042,020403s020ltr.pdf 9/16/2011
AP09/14/2011SLR30013020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020007s042,020403s020lbl.pdf 9/16/2011




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