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FDA Drug Application 021710 by VALIDUS PHARMS INC

Application Number021710
Application Type New Drug Application
Sponsor ApplicantVALIDUS PHARMS INC
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
AP012/10/2004N10788000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021710lbl.pdf 12/10/2004
AP012/10/2004N10789000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021710ltr.pdf 12/10/2004
AP012/10/2004N14426000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021710s000_EquetroTOC.cfm 7/5/2006
AP012/9/2006SLR15470003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021710s003lbl.pdf 12/14/2006
AP012/9/2006SLR15551003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021710s003ltr.pdf 12/28/2006
AP012/19/2007SLR18811005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021710s005ltr.pdf 1/9/2008
AP04/23/2009SLR22408006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021710s006ltr.pdf 5/4/2009
AP04/23/2009SLR22559006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021710s006lbl.pdf 5/13/2009
AP010/24/2010SLR26791008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021710s008ltr.pdf 10/27/2010
AP010/24/2010SLR26814008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008MedGuide.pdf 10/28/2010
AP010/24/2010SLR26815008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021710s008lbl.pdf 10/28/2010
AP011/13/2012SLR34380009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021710Orig1s009ltr.pdf 11/14/2012
AP011/13/2012SLR34396009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009mg.pdf 11/15/2012
AP011/13/2012SLR34397009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021710s009lbl.pdf 11/15/2012
AP19/23/2016SE847199011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021710Orig1s011,s012ltr.pdf 9/29/2016
AP19/23/2016SE847201011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf 9/29/2016
AP19/23/2016SE847200012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021710Orig1s011,s012ltr.pdf 9/29/2016
AP19/23/2016SE847202012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf 9/29/2016
AP01/27/2012SLR31593013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021710s013ltr.pdf 1/31/2012




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