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FDA Drug Application 021344 by ASTRAZENECA

Application Number021344
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
AP04/25/2002N1840000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21344.pdf 4/25/2002
AP04/25/2002N1841000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21344lbl.pdf 4/25/2002
AP04/25/2002N1842000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-344_FulvestrantFaslodex.cfm 4/25/2002
AP012/24/2003SE87514001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21344se8-001ltr.pdf 1/14/2004
AP012/24/2003SE87563001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21344se8-001_faslodex_lbl.pdf 1/15/2004
AP08/2/2005SLR12554004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021344s004ltr.pdf 8/8/2005
AP08/2/2005SLR12572004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021344s004lbl.pdf 8/8/2005
AP09/9/2010SLR26442007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf 9/10/2010
AP09/9/2010SLR26475007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf 9/13/2010
AP09/9/2010SE226476012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021344s007,s012ltr.pdf 9/13/2010
AP09/9/2010SE226443012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf 9/10/2010
AP05/17/2011SE528869013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s013ltr.pdf 5/19/2011
AP05/17/2011SE528899013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s013lbl.pdf 5/23/2011
AP09/26/2011SLR30093014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s014lbl.pdf 9/26/2011
AP09/26/2011SLR30134014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s014,s015ltr.pdf 9/29/2011
AP09/26/2011SLR30135015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021344s014,s015ltr.pdf 9/29/2011
AP09/26/2011SLR30094015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s015lbl.pdf 9/26/2011
AP07/13/2012SLR33208018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s018ltr.pdf 7/17/2012
AP07/13/2012SLR33275018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s018lbl.pdf 7/25/2012
AP011/9/2012SLR34341019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf 11/8/2012
AP011/9/2012SLR34359019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf 11/13/2012
AP011/9/2012SE834360020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021344Orig1s019,s020ltr.pdf 11/13/2012
AP011/9/2012SE834342020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf 11/8/2012
AP010/8/2013SCM       
AP010/8/2013SCM       
AP08/25/2014SCM       
AP03/1/2016SLR45336025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s025ltr.pdf 3/3/2016
AP03/1/2016SLR45345025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s025lbl.pdf 3/3/2016
AP03/2/2016SE845375026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s026ltr.pdf 3/4/2016
AP03/2/2016SE845380026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s026lbl.pdf 3/4/2016
AP05/19/2016SLR46079027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s027ltr.pdf 5/20/2016
AP05/19/2016SLR46102027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s027lbl.pdf 5/23/2016
AP07/12/2016SLR46516029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s029ltr.pdf 7/13/2016
AP07/12/2016SLR46525029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s029lbl.pdf 7/13/2016
AP06/30/2014SCM       
AP010/26/2016SLR47520031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021344Orig1s031ltr.pdf 10/31/2016




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