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FDA Drug Application 021332 by ASTRAZENECA AB

Application Number021332
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA AB
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
AP03/16/2005N11265000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021332ltr.pdf 3/18/2005
AP03/16/2005N11266000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf 3/18/2005
AP03/16/2005N11792000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin.cfm 6/14/2005
AP03/16/2005N15922000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf 2/28/2007
AP03/16/2005N43257000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=320 7/7/2015
AP09/25/2007SCP18032006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf 9/26/2007
AP09/25/2007SCP18158006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021332s006ltr.pdf 10/4/2007
AP06/27/2014SE839702007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf 6/30/2014
AP06/27/2014SE839721007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf 7/1/2014
AP08/4/2008SLR20511010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021332s010ltr.pdf 8/6/2008
AP06/27/2014SLR39701016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf 6/30/2014
AP06/27/2014SLR39722016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf 7/1/2014
AP01/3/2012SLR31339020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021332s020ltr.pdf 1/5/2012
AP02/25/2015SLR41933023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s023ltr.pdf 2/27/2015
AP02/25/2015SLR42005023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf 3/3/2015
AP08/7/2015S43616024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s024ltr.pdf 8/11/2015
AP03/20/2015SLR42252025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf 3/24/2015
AP03/20/2015SLR42514025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s025ltr.pdf 4/13/2015




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