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FDA Drug Application 021004 by GLAXOSMITHKLINE

Application Number021004
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/8/1998N1794000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir.cfm 12/8/1998
AP012/8/1998N4711000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_Approv.pdf 12/8/1998
AP012/8/1998N4712000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_prntlbl.pdf 12/8/1998
AP03/31/2000SLR       
AP08/16/2001SE11790002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf 8/16/2001
AP08/16/2001SE11791002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21004s2lbl.pdf 8/16/2001
AP08/16/2001SE11792002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-003SE1002_EpivirHBV.cfm 8/16/2001
AP09/13/2002SCM       
AP012/24/2002SCM       
AP011/13/2003SLR6984005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr005ltr.pdf 11/25/2003
AP011/13/2003SLR7010005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21003slr004,21004slr005_epivir_lbl.pdf 12/1/2003
AP011/22/2004SLR10681006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s005,21004s006ltr.pdf 12/2/2004
AP011/22/2004SLR10713006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf 12/3/2004
AP09/27/2004SLR10302007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s006,21004s007ltr.pdf 9/29/2004
AP09/27/2004SLR10303007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s006,21004s007lbl.pdf 9/29/2004
AP09/26/2007SLR18140010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010, 021004s010ltr.pdf 10/4/2007
AP09/26/2007SLR18177010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021003s010,021004s010lbl.pdf 10/4/2007
AP01/21/2011SLR27578013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.pdf 1/24/2011
AP01/21/2011SLR27622013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013ltr.pdf 1/27/2011
AP012/20/2013SLR38135015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.pdf 12/23/2013
AP012/20/2013SLR38156015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004Orig1s015ltr.pdf 12/24/2013




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