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FDA Drug Application 050706 by ASTRAZENECA

Application Number050706
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
AP06/21/1996N       
AP010/12/1999SCM       
AP05/23/2000SLR       
AP03/31/2000SCS       
AP02/6/2001SLR       
AP01/29/2001SCM       
AP07/23/2001SCM       
AP06/18/2002SCM       
AP06/5/2002SCS       
AP06/4/2004SLR9073016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50706slr016ltr.pdf 6/7/2004
AP05/25/2005SE111717018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050706s018ltr.pdf 5/26/2005
AP05/25/2005SE111724018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050706s018lbl.pdf 5/26/2005
AP05/25/2005SE117314018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050706_S018_MERREM.pdf 7/20/2007
AP08/17/2005SLR12635020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050706s020ltr.pdf 8/19/2005
AP03/27/2008SLR19538022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf 3/27/2008
AP03/27/2008SLR19574022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050706s022ltr.pdf 4/2/2008
AP03/13/2008SLR19471023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050706s023ltr.pdf 3/17/2008
AP03/13/2008SLR19478023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s023lbl.pdf 3/17/2008
AP08/6/2009SLR23746025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050706s025lbl.pdf 11/6/2009
AP08/6/2009SLR24058025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050706s025ltr.pdf 11/20/2009
AP012/23/2010SLR27371028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050706s028lbl.pdf 12/26/2010
AP012/23/2010SLR27413028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050706s028ltr.pdf 12/28/2010
AP03/28/2013SLR35585031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s031ltr.pdf 4/1/2013
AP03/28/2013SLR35617031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s031lbl.pdf 4/1/2013
AP012/16/2013SLR38075032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034ltr.pdf 12/17/2013
AP012/16/2013SLR38082032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf 12/17/2013
AP06/18/2014SCM       
AP012/16/2013SLR38076034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050706Orig1s032,s034ltr.pdf 12/17/2013
AP012/16/2013SLR38083034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050706s032s034lbl.pdf 12/17/2013
AP012/16/2013SLR39776034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/050706Orig1s034.pdf 7/7/2014
AP012/19/2014SLR41394035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050706Orig1s035ltr.pdf 12/24/2014
AP012/19/2014SLR41583035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050706s035lbl.pdf 1/9/2015
AP07/27/2016SLR46665036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050706s036lbl.pdf 7/28/2016
AP07/27/2016SLR46677036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050706Orig1s036ltr.pdf 7/28/2016




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