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FDA Drug Application 021003 by GLAXOSMITHKLINE

Application Number021003
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
AP012/8/1998N1793000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir.cfm 12/8/1998
AP012/8/1998N4709000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_Approv.pdf 12/8/1998
AP012/8/1998N4710000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21003_Epivir-HBV_prntlbl.pdf 12/8/1998
AP03/31/2000SLR       
AP08/16/2001SE11787002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21004s2ltr.pdf 8/16/2001
AP08/16/2001SE11788002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21004s2lbl.pdf 8/16/2001
AP08/16/2001SE11789002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-003SE1002_EpivirHBV.cfm 8/16/2001
AP09/13/2002SCM       
AP011/13/2003SLR6983004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21003slr004,21004slr005ltr.pdf 11/25/2003
AP011/13/2003SLR7009004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21003slr004,21004slr005_epivir_lbl.pdf 12/1/2003
AP011/22/2004SLR10680005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s005,21004s006ltr.pdf 12/2/2004
AP011/22/2004SLR10712005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s005,21004s006lbl.pdf 12/3/2004
AP09/27/2004SLR10301006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21003s006,21004s007ltr.pdf 9/29/2004
AP09/27/2004SLR10304006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21003s006,21004s007lbl.pdf 9/29/2004
AP09/26/2007SLR18139010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021003s010, 021004s010ltr.pdf 10/4/2007
AP09/26/2007SLR18176010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021003s010,021004s010lbl.pdf 10/4/2007
AP01/21/2011SLR27579013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021003s013,021004s013lbl.pdf 1/24/2011
AP01/21/2011SLR27621013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021003s013,021004s013ltr.pdf 1/27/2011
AP012/20/2013SLR38134015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021003s015,021004s015lbl.pdf 12/23/2013
AP012/20/2013SLR38155015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021003Orig1s015.021004Orig1s015ltr.pdf 12/24/2013




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