Back to FDA Applications sponsored by GLAXOSMITHKLINE

FDA Drug Application 020550 by GLAXOSMITHKLINE

Application Number020550
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/15/1995N       
AP010/4/1996SE1       
AP010/18/1996SLR       
AP09/26/1997SE14348003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020550ap.pdf 9/26/1997
AP04/30/1997SLR       
AP04/1/2003SE14765005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s005lbl.pdf 4/1/2003
AP04/1/2003SE15378005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-005ltr.pdf 4/18/2003
AP011/25/1998SCM       
AP02/2/1999SCP       
AP07/22/1999SCM       
AP04/20/2000SLR       
AP06/25/2001SLR5472010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf 4/25/2003
AP04/20/2000SLR       
AP06/25/2001SE25473012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s12lbl.pdf 4/25/2003
AP06/25/2001SE29361012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-550S012_Valacyclovir.cfm 6/14/2004
AP06/25/2001SE29608012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-550S012_Valacyclovir%20hydrochloride_Approv.pdf 6/29/2004
AP06/25/2001SLR5474013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20550s10s13lbl.pdf 4/25/2003
AP06/1/2001SCM       
AP03/14/2002SCS       
AP09/9/2002SE12152016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20550se1-016ltr.pdf 9/9/2002
AP07/3/2002SCM       
AP012/18/2002SCS       
AP08/29/2003SE16591019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020550s019lbl.pdf 8/29/2003
AP08/29/2003SE16609019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550se1-019ltr.pdf 9/9/2003
AP08/8/2003SLR6532021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20550slr021ltr.pdf 8/15/2003




Back to FDA Applications sponsored by GLAXOSMITHKLINE

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.