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FDA Drug Application 022200 by ASTRAZENECA AB

Application Number022200
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA AB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/27/2012N31567000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022200Orig1s000_corrected_ltr.pdf 1/27/2012
AP01/27/2012N31568000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf 1/27/2012
AP01/27/2012N31569000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200s000mg.pdf 1/27/2012
AP01/27/2012N32901000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000TOC.cfm 6/12/2012
AP01/27/2012N32902000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf 6/12/2012
AP06/12/2013SCM       
AP02/27/2013SCM       
AP02/28/2014SLR38648008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf 3/4/2014
AP02/28/2014SLR38660008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s008ltr.pdf 3/5/2014
AP02/28/2014SLR40150008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022200Orig1s008.pdf 8/5/2014
AP03/24/2014SCM       
AP04/29/2015S42734010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s010ltr.pdf 5/5/2015
AP08/14/2015SCM       
AP05/22/2014SLR39386012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf 5/28/2014
AP05/22/2014SLR39355012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf 5/27/2014
AP05/22/2014SLR39356013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf 5/27/2014
AP05/22/2014SLR39387013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf 5/28/2014
AP03/5/2015SCM42042014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s014ltr.pdf 3/6/2015
AP03/5/2015SCM42055014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf 3/9/2015
AP09/24/2015SE843999015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf 9/28/2015
AP09/24/2015SE844143015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf 10/6/2015
AP09/24/2015SE844147016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf 10/7/2015
AP09/24/2015SE844000016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf 9/28/2015
AP09/24/2015SE844001017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf 9/28/2015
AP09/24/2015SE844148017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf 10/7/2015
AP09/24/2015SE844149018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf 10/7/2015
AP09/24/2015SE844002018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf 9/28/2015
AP03/9/2015SLR42099019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s019ltr.pdf 3/11/2015
AP03/9/2015SLR42304019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf 3/27/2015
AP09/18/2015SLR43935020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s020ltr.pdf 9/22/2015
AP09/18/2015SLR43958020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf 9/23/2015
AP012/31/2015SCM       
AP012/23/2015SCM       
AP01/11/2016SCM       
AP06/10/2016SCM       




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