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FDA Drug Application 021093 by ASTRAZENECA

Application Number021093
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP09/5/2000N1199000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21093ltr.pdf 9/5/2000
AP09/5/2000N1200000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf 9/5/2000
AP09/5/2000N8756000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-093_AtacandHCT.cfm 5/27/2004
AP09/5/2000N31203000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP011/28/2001SLR       
AP07/3/2002SCM       
AP012/16/2004SLR10851004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21093s004ltr.pdf 12/30/2004
AP08/17/2006SLR14717006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf 8/18/2006
AP08/17/2006SLR14728006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021093s006LTR.pdf 8/18/2006
AP05/16/2008SCF19851008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021093s008ltr.pdf 5/20/2008
AP03/11/2011SLR28217012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf 3/11/2011
AP03/11/2011SLR28254012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf 3/16/2011
AP06/14/2011SLR29176013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s013lbl.pdf 6/16/2011
AP06/14/2011SLR29226013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021093s013ltr.pdf 6/17/2011
AP03/29/2012SLR32312015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021093s015lbl.pdf 3/29/2012
AP03/29/2012SLR32322015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021093s015ltr.pdf 4/2/2012
AP02/9/2015SLR41810016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf 2/10/2015
AP02/9/2015SLR41814016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021093Orig1s016ltr.pdf 2/10/2015
AP04/26/2013SLR35861018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021093s018lbl.pdf 4/29/2013
AP04/26/2013SLR35885018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021093Orig1s018ltr.pdf 4/30/2013
AP02/9/2016SLR45143019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021093Orig1s019ltr.pdf 2/11/2016
AP02/9/2016SLR45388019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf 3/4/2016




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