Back to FDA Applications sponsored by GLAXOSMITHKLINE

FDA Drug Application 020487 by GLAXOSMITHKLINE

Application Number020487
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/1995N       
AP09/8/1995SCS11901002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-487s002_ValtrexTOC.cfm 6/27/2005
AP08/9/1996SCS11902003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20-487s003_ValtrexTOC.cfm 6/27/2005
AP01/13/1997SLR11903004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-487s004_ValtrexTOC.cfm 6/27/2005
AP012/3/2004SLR10772005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20487s005ltr.pdf 12/8/2004
AP012/3/2004SLR10773005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20487s005lbl.pdf 12/8/2004
AP012/3/2004SLR11906005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-487s005_ValtrexTOC.cfm 6/27/2005
AP011/22/2005SLR13138007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020487s007rel2_lbl.pdf 11/30/2005
AP011/22/2005SLR13156007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020487s007rel2_ltr.pdf 11/30/2005
AP012/11/2007SLR18659013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020487s013lbl.pdf 12/14/2007
AP012/11/2007SLR18854013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020487s013ltr.pdf 1/9/2008
AP09/3/2008SE520732014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf 9/3/2008
AP09/3/2008SE520757014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020487s014ltr.pdf 9/9/2008
AP04/19/2010SLR25314016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020487s016lbl.pdf 4/20/2010
AP04/19/2010SLR25332016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020487s016ltr.pdf 4/22/2010




Back to FDA Applications sponsored by GLAXOSMITHKLINE