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FDA Drug Application 022433 by ASTRAZENECA LP

Application Number022433
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA LP
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
AP07/20/2011N29562000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022433s000lbl.pdf 7/20/2011
AP07/20/2011N29563000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM264220.pdf 7/20/2011
AP07/20/2011N29564000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022433Orig1s000ltr.pdf 7/20/2011
AP07/20/2011N29565000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM264004.pdf 7/21/2011
AP07/20/2011N29842000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000TOC.cfm 8/23/2011
AP07/20/2011N29843000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000SumR.pdf 8/23/2011
AP012/5/2012SCM       
AP011/9/2012SCM       
AP01/24/2013N34989006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s006ltr.pdf 1/28/2013
AP01/24/2013N35013006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s006lbl.pdf 1/30/2013
AP03/29/2013SLR35588008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s008ltr.pdf 4/1/2013
AP03/29/2013SLR35621008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s008lbl.pdf 4/1/2013
AP010/30/2013SE837625009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s009ltr.pdf 10/31/2013
AP012/13/2013SLR38066010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s010ltr.pdf 12/17/2013
AP012/13/2013SLR38094010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s010lbl.pdf 12/17/2013
AP03/7/2014SCM       
AP07/18/2014SCM       
AP03/26/2015SLR42310013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s013ltr.pdf 3/27/2015
AP03/26/2015SLR42319013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s013lbl.pdf 3/27/2015
AP06/24/2015SCM       
AP09/3/2015SE845141015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022433Orig1s015TOC.cfm 2/10/2016
AP09/3/2015SE846660015Priority 3 Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022433Orig1s015(2).pdf 7/28/2016
AP09/3/2015SE843825015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s015ltr.pdf 9/8/2015
AP09/3/2015SE843829015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s015lbl.pdf 9/8/2015
AP09/16/2015SCM       
AP09/21/2015SLR43946017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s017ltr.pdf 9/22/2015
AP09/21/2015SLR43953017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s017lbl.pdf 9/23/2015
AP07/22/2016SLR46601018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s018lbl.pdf 7/25/2016
AP07/22/2016SLR46608018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022433Orig1s018ltr.pdf 7/26/2016
AP18/11/2016SLR46835019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433Orig1s019lbl.pdf 8/22/2016
AP09/23/2016SLR47163020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022433Orig1s020ltr.pdf 9/26/2016
AP09/23/2016SLR47197020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s020lbl.pdf 9/29/2016




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