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FDA Drug Application 020095 by GLAXOSMITHKLINE

Application Number020095
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP03/8/1994N       
AP04/4/1994SLR       
AP011/3/1994SLR       
AP011/14/1994SLR       
AP03/29/1995SLR       
AP011/27/1996SLR5513006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm 4/29/2003
AP010/29/1999SLR5514007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules.cfm 4/29/2003
AP010/29/1999SLR9655007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules_approv.pdf 7/1/2004
AP09/12/1997SCM       
AP010/22/1999SLR       
AP010/22/1999SLR       
AP010/29/1999SLR       
AP05/9/2001SLR       
AP01/7/2002SLR2031013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf 1/7/2002
AP01/15/2002SCS       




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