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FDA Drug Application 018703 by GLAXO GRP LTD

Application Number018703
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/9/1983N       
AP01/5/1984SCM       
AP06/28/1985SES       
AP02/28/1984SCS       
AP05/30/1986SE1       
AP08/27/1984SLR       
AP012/9/1985SE2       
AP09/13/1984SCP       
AP05/30/1986SE1       
AP02/4/1985SCE       
AP02/22/1985SCS       
AP012/9/1985SCS       
AP08/23/1985SCP       
AP011/20/1985SCP       
AP02/20/1986SCS       
AP012/9/1985SLR       
AP08/8/1986SCS       
AP010/27/1986SCS       
AP010/27/1986SCP       
AP03/6/1987SLR       
AP04/24/1987SCE       
AP08/27/1987SCM       
AP010/29/1987SLR       
AP05/20/1988SLR       
AP05/20/1988SLR       
AP09/30/1988SCS       
AP09/29/1988SCS       
AP02/3/1989SLR       
AP010/25/1988SLR       
AP08/8/1989SCM       
AP02/6/1990SCM       
AP05/18/1989SLR       
AP01/4/1991SCS       
AP01/4/1991SCS       
AP011/25/1991SLR       
AP07/16/1990SLR       
AP012/12/1990SCM       
AP011/21/1990SLR       
AP012/20/1990SCM       
AP05/19/1992SE1       
AP07/2/1992SCP       
AP07/22/1992SCS       
AP02/28/1994SE2       
AP011/3/1994SE1       
AP04/5/1993SLR       
AP06/3/1993SCP       
AP03/29/1995SE1       
AP010/19/1994SCM       
AP01/26/1996SCM       
AP011/3/1994SLR       
AP011/27/1996SLR       
AP010/29/1999SE85530056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18703S56_zantac.cfm 4/30/2003
AP010/29/1999SE89656056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18703S56_zantac_approv.pdf 7/1/2004
AP010/22/1999SLR       
AP010/22/1999SLR       
AP010/29/1999SLR       
AP05/9/2001SLR       
AP01/7/2002SLR2029061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf 1/7/2002
AP01/15/2002SCS       
AP04/28/2005SLR11542065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf 5/2/2005
AP04/28/2005SLR11543065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf 5/2/2005
AP07/12/2006SLR14506066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf 7/21/2006
AP02/17/2009SLR21872067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf 2/19/2009
AP02/17/2009SLR22127067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf 3/27/2009
AP09/4/2009SLR23545068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf 10/6/2009
AP09/4/2009SLR23854068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf 11/12/2009




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