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FDA Drug Application 020578 by ASTRAZENECA

Application Number020578
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP01/11/1996N31118000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP04/14/1999SLR       
AP06/9/1997SCS       
AP07/27/1998SE12143003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf 7/27/1998
AP07/27/1998SE12144003   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf 7/27/1998
AP07/27/1998SE12145003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s024_Zoladax.cfm 7/27/1998
AP011/13/1997SCS       
AP07/16/1998SCM       
AP09/18/1998SCM       
AP012/7/1998SCM       
AP03/4/1999SCM       
AP011/3/1999SLR       
AP06/20/2000SCS       
AP010/16/2000SCS       
AP03/9/2001SCM       
AP02/5/2002SLR2137013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20578s13ltr.pdf 2/5/2002
AP02/28/2002SLR2136016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf 2/28/2002
AP06/24/2004SLR9547020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf 6/25/2004
AP010/19/2005SLR12972025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046ltr.pdf 10/25/2005
AP08/31/2009SLR23374028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf 9/17/2009
AP08/31/2009SLR24534028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf 1/20/2010
AP08/31/2009SLR24535029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf 1/20/2010
AP08/31/2009SLR23375029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf 9/17/2009
AP08/31/2009SLR23376030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf 9/17/2009
AP08/31/2009SLR24536030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf 1/20/2010
AP01/14/2011SLR27557032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf 1/20/2011
AP01/14/2011SLR27571032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf 1/20/2011
AP06/18/2013SLR36326034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf 6/17/2013
AP06/18/2013SLR36354034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf 6/20/2013
AP06/18/2013SLR36355035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf 6/20/2013
AP06/18/2013SLR36327035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf 6/17/2013
AP010/7/2014SLR40735036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578Orig1s036ltr.pdf 10/9/2014
AP010/7/2014SLR40746036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf 10/9/2014
AP02/12/2015SLR41845037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf 2/13/2015
AP02/12/2015SLR41852037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578Orig1s037ltr.pdf 2/17/2015




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