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FDA Drug Application 020838 by ASTRAZENECA

Application Number020838
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP06/4/1998N347000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20838ltr.pdf 6/4/1998
AP06/4/1998N348000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf 6/4/1998
AP06/4/1998N5650000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20838_Atacand.cfm 5/22/2003
AP06/4/1998N31202000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP012/7/1998SCM       
AP011/16/1998SCM       
AP07/28/1999SCS       
AP08/11/1999SCP       
AP012/8/1999SCP       
AP06/14/2000SLR8759008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20838-s008_atacand.pdf 5/27/2004
AP012/27/2000SCM       
AP06/7/2001SCM       
AP04/2/2001SCM       
AP05/24/2001SCM       
AP03/29/2001SCP       
AP010/4/2001SCS       
AP09/13/2002SE44559015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20838se4-015ltr.pdf 9/13/2002
AP09/13/2002SE44560015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf 9/13/2002
AP09/13/2002SE48758015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20838s015_Atacand.cfm 5/27/2004
AP011/28/2001SLR       
AP01/22/2003SLR8757017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr017ltr.pdf 5/27/2004
AP04/23/2003SLR5722019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20838slr019ltr.pdf 5/29/2003
AP05/18/2005SE111669022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020838s022ltr.pdf 5/20/2005
AP05/18/2005SE111689022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf 5/20/2005
AP012/16/2004SLR10856023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20838s023ltr.pdf 12/30/2004
AP02/22/2005SE111142024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20838s024ltr.pdf 2/23/2005
AP02/22/2005SE111171024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf 2/23/2005
AP08/17/2006SLR14737026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020838s026LTR.pdf 8/21/2006
AP08/17/2006SLR14743026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf 8/21/2006
AP010/22/2009SE523670031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf 10/23/2009
AP010/22/2009SE523732031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020838s031ltr.pdf 11/5/2009
AP04/13/2012SLR32438032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s032ltr.pdf 4/16/2012
AP04/13/2012SLR32443032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf 4/17/2012
AP06/24/2011SLR29307033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf 6/28/2011
AP06/24/2011SLR29387033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020838s033ltr.pdf 7/5/2011
AP04/27/2012SLR32569035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf 5/1/2012
AP04/27/2012SLR32591035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020838s035ltr.pdf 5/2/2012
AP02/6/2015SLR41806036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf 2/9/2015
AP02/6/2015SLR41807036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020838Orig1s036ltr.pdf 2/10/2015
AP02/21/2013SCM       
AP04/26/2013SLR35862038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf 4/29/2013
AP04/26/2013SLR35884038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020838Orig1s038ltr.pdf 4/30/2013
AP02/9/2016SLR45142039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020838Orig1s039ltr.pdf 2/11/2016
AP02/9/2016SLR45152039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf 2/11/2016




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