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FDA Drug Application 022522 by ASTRAZENECA PHARMS

Application Number022522
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
AP02/28/2011N28091000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022522s000ltr.pdf 3/7/2011
AP02/28/2011N28192000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022522s000lbl.pdf 3/10/2011
AP02/28/2011N28541000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000TOC.cfm 4/14/2011
AP02/28/2011N28542000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000SumR.pdf 4/14/2011
AP02/28/2011N31356000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM286063.pdf 1/6/2012
AP04/11/2012SCM       
AP012/18/2012SCM       
AP08/23/2013SLR36895003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf 8/27/2013
AP08/23/2013SLR36903003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022522Orig1s003ltr.pdf 8/27/2013
AP09/17/2014SCM       
AP011/24/2015SLR44579006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022522Orig1s006ltr.pdf 11/25/2015
AP011/24/2015SLR44581006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022522s006lbl.pdf 11/25/2015
AP02/12/2016SCM       




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