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FDA Drug Application 020251 by GLAXO GRP LTD

Application Number020251
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
AP03/31/1994N       
AP011/3/1994SLR       
AP011/14/1994SLR       
AP03/29/1995SLR       
AP011/27/1996SLR       
AP010/29/1999SLR5511006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm 4/29/2003
AP010/29/1999SLR9653006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantacefferdose_approv.pdf 7/1/2004
AP010/22/1999SLR       
AP010/22/1999SLR       
AP010/29/1999SLR       
AP05/9/2001SLR       
AP01/7/2002SLR2032011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf 1/7/2002
AP01/15/2002SCS       
AP04/1/2004SCF8309015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20251scf015ltr.pdf 4/7/2004
AP04/1/2004SCF8473015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20251scf015_zantac_lbl.pdf 5/3/2004
AP04/28/2005SLR11546016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018703s065,019675s031,020251s016ltr.pdf 5/2/2005
AP04/28/2005SLR11547016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf 5/2/2005
AP07/12/2006SLR14504017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018703s066, 019675s032, 020251s017_ltr.pdf 7/21/2006
AP02/17/2009SLR21871018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s067,019675s034,020251s018ltr.pdf 2/19/2009
AP02/17/2009SLR22129018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s067,019675s034,020251s018lbl.pdf 3/27/2009
AP09/4/2009SLR23543019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf 10/6/2009
AP09/4/2009SLR23856019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf 11/12/2009




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