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FDA Drug Application 020541 by ASTRAZENECA

Application Number020541
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
AP012/27/1995N       
AP010/18/1996SLR       
AP02/6/1998SLR       
AP09/19/1997SLR       
AP08/13/1998SCM       
AP010/7/2002SLR4550005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541slr005,009ltr.pdf 10/7/2002
AP09/1/2000SE11452006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20541S06LTR.PDF 9/1/2000
AP09/1/2000SE14551006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex_prntlbl.pdf 9/1/2000
AP09/1/2000SE18751006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-541S006_Arimidex.cfm 5/27/2004
AP08/2/2001SCM       
AP09/10/2001SCM       
AP09/5/2002SE14548010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20541se1-010ltr.pdf 9/5/2002
AP09/5/2002SE14549010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20541s10lbl.pdf 9/5/2002
AP09/5/2002SE16109010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-541s010_Arimidex.cfm 7/8/2003
AP08/30/2004SLR10108015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020541s015.pdf 9/3/2004
AP08/30/2004SLR10125015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20541s015ltr.pdf 9/3/2004
AP09/16/2005SE712806016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020541s016lbl.pdf 9/22/2005
AP09/16/2005SE712817016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020541s016ltr.pdf 9/22/2005
AP012/10/2008SLR21358020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf 12/18/2008
AP012/10/2008SLR21492020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf 1/2/2009
AP012/10/2008SLR21493021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf 1/2/2009
AP012/10/2008SLR21357023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020541s020, s023ltr.pdf 12/18/2008
AP012/10/2008SLR21494023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020541s020s021s023lbl.pdf 1/2/2009
AP04/30/2009SE722442024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf 5/6/2009
AP04/30/2009SE722490024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf 5/11/2009
AP04/30/2009SLR22443025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020541s024,s025ltr.pdf 5/6/2009
AP04/30/2009SLR22491025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020541s024s025lbl.pdf 5/11/2009
AP04/18/2011SE828584026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf 4/18/2011
AP04/18/2011SE828585026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020541s026ltr.pdf 4/20/2011
AP05/1/2013SLR35949027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020541Orig1s027ltr.pdf 5/7/2013
AP05/1/2013SLR36017027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020541s027lbl.pdf 5/9/2013
AP05/2/2014SLR39216029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020541Orig1s029ltr.pdf 5/6/2014
AP05/2/2014SLR39231029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020541s029lbl.pdf 5/6/2014




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