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FDA Drug Application 019675 by GLAXO GRP LTD

Application Number019675
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1988N3778000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019675a_clinpharm_rev.pdf 2/4/1998
AP08/8/1989SCM       
AP05/18/1989SLR       
AP011/25/1991SLR       
AP07/16/1990SLR       
AP012/12/1990SCM       
AP011/21/1990SLR       
AP012/20/1990SCM       
AP05/19/1992SLR       
AP07/22/1992SCS       
AP02/28/1994SLR       
AP011/3/1994SLR       
AP04/5/1993SLR       
AP01/30/1995SCP       
AP03/29/1995SE1       
AP011/3/1994SLR       
AP011/27/1996SLR       
AP010/29/1999SLR5551020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup.cfm 4/30/2003
AP010/29/1999SLR5554020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19675S20_zantacsyrup_approv.pdf 4/30/2003
AP010/22/1999SLR       
AP010/22/1999SLR       
AP010/29/1999SLR       
AP05/9/2001SLR       
AP01/7/2002SLR2030025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf 1/7/2002
AP01/15/2002SCS       
AP09/24/2002SCM       
AP04/30/2004SCS8550030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19675scs030ltr.pdf 5/7/2004
AP04/28/2005SLR11544031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf 5/2/2005
AP04/28/2005SLR11545031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf 5/2/2005
AP07/12/2006SLR14505032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf 7/21/2006
AP02/17/2009SLR21873034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf 2/19/2009
AP02/17/2009SLR22128034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf 3/27/2009
AP09/4/2009SLR23544035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf 10/6/2009
AP09/4/2009SLR23855035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf 11/12/2009




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