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FDA Drug Application 019726 by ASTRAZENECA

Application Number019726
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
AP012/29/1989N31117000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP01/17/1991SCS       
AP02/26/1991SLR       
AP08/15/1991SCS       
AP02/2/1993SE1       
AP04/28/1992SLR       
AP03/29/1994SLR       
AP01/6/1994SCS       
AP01/6/1994SLR       
AP04/7/1994SCS       
AP010/31/1994SCS       
AP05/12/1995SCS       
AP02/14/1996SCS       
AP012/18/1995SLR       
AP06/27/1997SE14362018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19726S018_Zoladex.cfm 6/27/1997
AP02/4/1997SLR       
AP06/9/1997SCS       
AP08/20/1997SCS       
AP04/9/1998SE12141022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s022_zoladax.pdf 4/9/1998
AP011/13/1997SCS       
AP07/27/1998SE1537024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf 7/27/1998
AP07/27/1998SE1538024   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf 7/27/1998
AP07/27/1998SE12142024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s024_Zoladax.cfm 7/27/1998
AP09/18/1998SCM       
AP012/7/1998SCM       
AP01/20/1999SCM       
AP011/3/1999SLR       
AP012/10/1999SCM       
AP010/16/2000SCS       
AP02/5/2002SLR2138034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s34ltr.pdf 2/5/2002
AP02/5/2002SLR2139034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s022_zoladax.pdf 2/5/2002
AP01/29/2002SCM       
AP02/28/2002SLR2134037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf 2/28/2002
AP09/13/2002SCM       
AP06/24/2004SLR9546042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf 6/25/2004
AP010/19/2005SLR12971046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046ltr.pdf 10/25/2005
AP08/31/2009SLR23382050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf 9/17/2009
AP08/31/2009SLR24460050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf 1/7/2010
AP08/31/2009SLR23383051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf 9/17/2009
AP08/31/2009SLR24461051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf 1/7/2010
AP08/31/2009SLR23385052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019726s050s051s052lbl.pdf 9/17/2009
AP08/31/2009SLR24462052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019726s050,s051,s052ltr.pdf 1/7/2010
AP01/14/2011SLR27556054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf 1/20/2011
AP01/14/2011SLR27570054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019726s054lbl.pdf 1/20/2011
AP06/18/2013SLR36324056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf 6/17/2013
AP06/18/2013SLR36352056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf 6/20/2013
AP06/18/2013SLR36325057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019726s056,019726s057lbl.pdf 6/17/2013
AP06/18/2013SLR36353057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf 6/20/2013
AP010/7/2014SLR40734058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578Orig1s036ltr.pdf 10/9/2014
AP010/7/2014SLR40747058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf 10/9/2014
AP02/12/2015SLR41844059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf 2/13/2015
AP02/12/2015SLR41851059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578Orig1s037ltr.pdf 2/17/2015
AP07/19/2016SCM       




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