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FDA Drug Application 020498 by ASTRAZENECA

Application Number020498
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP010/4/1995N       
AP011/12/1997SCS       
AP012/12/1997SE1       
AP011/4/1999SCM       
AP012/11/2000SCM       
AP02/28/2001SLR       
AP010/25/2001SCM       
AP01/25/2002SCS       
AP09/23/2002SCM       
AP05/11/2005SLR11607016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020498s016ltr.pdf 5/17/2005
AP05/11/2005SLR11636016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020498s016lbl.pdf 5/17/2005
AP03/10/2006SLR13756018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020498s018lbl.pdf 3/14/2006
AP03/10/2006SLR13807018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020498s018ltr.pdf 3/23/2006
AP02/10/2009SLR21815019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf 2/12/2009
AP02/10/2009SLR22004019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf 3/16/2009
AP02/10/2009SLR21816021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020498s019s021lbl.pdf 2/12/2009
AP02/10/2009SLR22003021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020498s019,s021ltr.pdf 3/16/2009
AP09/15/2010SLR26500022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020498s022ltr.pdf 9/20/2010
AP09/15/2010SLR26505022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020498s022lbl.pdf 9/20/2010
AP09/12/2013SCM       
AP02/27/2015SLR41977025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020498Orig1s025ltr.pdf 3/2/2015
AP02/27/2015SLR42016025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020498s025lbl.pdf 3/4/2015




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