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FDA Drug Application 021345 by MYLAN IRELAND LTD

Application Number021345
Application Type New Drug Application
Sponsor ApplicantMYLAN IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/7/2001N4555000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-345_Arixtra_Approv.pdf 12/7/2001
AP012/7/2001N4556000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21345lbl.pdf 12/7/2001
AP012/7/2001N8753000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-345_Arixtra.cfm 5/27/2004
AP012/4/2002SLR4553001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21345slr001ltr.pdf 12/4/2002
AP012/4/2002SLR4554001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21345slr001_arixtra_lbl.pdf 12/4/2002
AP06/17/2003SE15976002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21345se1-002ltr.pdf 6/22/2003
AP06/17/2003SE15986002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21345se1-002_arixtra_lbl.pdf 6/22/2003
AP05/28/2004SE18852004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf 6/1/2004
AP05/28/2004SE18869004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21345se1-004,005ltr.pdf 6/1/2004
AP05/28/2004SE18870005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21345se1-004,005ltr.pdf 6/1/2004
AP05/28/2004SE18853005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf 6/1/2004
AP05/26/2005SE111733010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021345s010ltr.pdf 5/27/2005
AP05/26/2005SE111738010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021345s010lbl.pdf 5/27/2005
AP010/17/2008SCA21042018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021345s018ltr.pdf 10/21/2008
AP08/14/2009SLR23402019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s019lbl.pdf 9/18/2009
AP08/14/2009SLR24138019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021345s019ltr.pdf 11/25/2009
AP03/26/2010SLR25157023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021345s023ltr.pdf 3/31/2010
AP03/26/2010SLR25201023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf 4/4/2010
AP012/23/2009SLR24377025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s025lbl.pdf 12/30/2009
AP012/23/2009SLR24382025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021345s025ltr.pdf 12/31/2009
AP09/12/2013SLR37092030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021345Orig1s030ltr.pdf 9/13/2013
AP09/12/2013SLR37114030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021345s030lbl.pdf 9/17/2013
AP011/15/2013SCM       
AP07/15/2014SLR39881032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021345s032lbl.pdf 7/17/2014
AP07/15/2014SLR39893032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021345Orig1s032ltr.pdf 7/17/2014
AP04/11/2016SCM       




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