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FDA Drug Application 202450 by ASTRAZENECA PHARMS

Application Number202450
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
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
AP07/23/2012N33263000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202450s000lbl.pdf 7/24/2012
AP07/23/2012N33274000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202450Orig1s000ltr.pdf 7/25/2012
AP07/23/2012N33647000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000TOC.cfm 9/5/2012
AP07/23/2012N33648000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000SumR.pdf 9/5/2012
AP05/3/2013SCM       
AP07/17/2014SLR39900002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s002ltr.pdf 7/21/2014
AP07/17/2014SLR39914002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202450s002lbl.pdf 7/22/2014
AP010/30/2014SLR40920003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s003ltr.pdf 11/3/2014
AP010/23/2014SCM       
AP04/3/2015SLR42427005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202450Orig1s005ltr.pdf 4/6/2015
AP04/3/2015SLR42453005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202450s005lbl.pdf 4/7/2015
AP03/16/2016SLR45451006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202450s006lbl.pdf 3/17/2016
AP03/16/2016SLR45453006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202450Orig1s006ltr.pdf 3/18/2016
AP03/24/2016SCM       




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