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FDA Drug Application 200678 by ASTRAZENECA AB

Application Number200678
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA AB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/5/2010N26927000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200678s000ltr.pdf 11/12/2010
AP011/5/2010N26950000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf 11/12/2010
AP011/5/2010N30006000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678_kombiglyze_xr_toc.cfm 9/16/2011
AP011/5/2010N30007000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf 9/16/2011
AP011/5/2010N36275000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280360.pdf 6/12/2013
AP05/15/2013SCM       
AP03/7/2012SE132089003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf 3/13/2012
AP03/7/2012SE132074003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004mg.pdf 3/9/2012
AP03/7/2012SE132076003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf 3/9/2012
AP03/7/2012SE832077004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf 3/9/2012
AP03/7/2012SE832075004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004mg.pdf 3/9/2012
AP03/7/2012SE832090004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf 3/13/2012
AP011/15/2011SLR30618005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf 11/16/2011
AP011/15/2011SLR30619005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005MG.pdf 11/16/2011
AP011/15/2011SLR30655005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200678s005ltr.pdf 11/21/2011
AP04/1/2012SLR32356007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s007ltr.pdf 4/5/2012
AP011/8/2012SCM       
AP05/24/2013SE836151010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200678Orig1s010ltr.pdf 5/28/2013
AP05/24/2013SE836224010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf 6/4/2013
AP04/5/2016SE845594013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf 4/7/2016
AP04/5/2016SE847034013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf 9/13/2016
AP02/9/2015SCM       
AP08/28/2015SLR43763016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf 9/1/2015
AP08/28/2015SLR43802016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf 9/4/2015




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