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FDA Drug Application 018603 by GLAXOSMITHKLINE

Application Number018603
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; New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/22/1982N       
AP012/14/1982SCS       
AP01/5/1983SCE       
AP02/9/1990SE1       
AP08/30/1983SCM       
AP05/8/1984SCM       
AP08/14/1984SCE       
AP05/31/1984SCM       
AP07/9/1984SLR       
AP02/9/1990SE1       
AP04/22/1993SLR       
AP06/29/1989SCP       
AP07/17/1992SCS       
AP04/22/1993SLR       
AP011/9/1993SCS       
AP04/14/1994SLR       
AP06/7/1995SCM       
AP010/29/1996SCS       
AP06/2/1998SE1453019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/18603s19ltr.pdf 6/2/1998
AP06/2/1998SE1454019   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/18603s19lbl.pdf 6/2/1998
AP05/19/1999SLR       
AP07/15/1999SCS       
AP07/12/2000SCM       
AP01/29/2002SLR2210023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf 1/29/2002
AP01/29/2002SLR2212024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf 1/29/2002
AP01/29/2002SLR2213025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18603s25ltr.pdf 1/29/2002
AP05/19/2004SLR8674027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18603slr027ltr.pdf 5/27/2004
AP05/19/2004SLR8686027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18603slr027_zovirax_lbl.pdf 5/27/2004




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