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FDA Drug Application 022192 by VANDA PHARMS INC

Application Number022192
Application Type New Drug Application
Sponsor ApplicantVANDA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/6/2009N22482000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022192lbl.pdf 5/11/2009
AP05/6/2009N22517000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022192s000ltr.pdf 5/11/2009
AP05/6/2009N22744000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm 6/12/2009
AP05/6/2009N22745000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022192s000TOC.cfm 6/12/2009
AP05/6/2009N31189000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP08/24/2010SLR26286001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s001ltr.pdf 8/26/2010
AP08/24/2010SLR26289001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s001lbl.pdf 8/27/2010
AP012/1/2010SLR27189002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s002lbl.pdf 12/4/2010
AP012/1/2010SLR27193002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s002ltr.pdf 12/6/2010
AP03/21/2011SLR28335004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s004ltr.pdf 3/24/2011
AP03/21/2011SLR28379004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s004lbl.pdf 3/28/2011
AP09/7/2011SLR29970005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf 9/12/2011
AP09/7/2011SLR29974005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf 9/12/2011
AP09/7/2011SLR29971006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022192s005s006lbl.pdf 9/12/2011
AP09/7/2011SLR29975006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022192s005,s006ltr.pdf 9/12/2011
AP01/31/2013SLR35043007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022192s007lbl.pdf 2/1/2013
AP01/31/2013SLR35048007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022192Orig1s007ltr.pdf 2/4/2013
AP01/27/2012SLR31587009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022192s009lbl.pdf 1/30/2012
AP01/27/2012SLR31594009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022192s009ltr.pdf 1/31/2012
AP07/12/2013SCM       
AP05/30/2013SCM       
AP07/19/2013SCM       
AP04/21/2014SLR39114013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022192Orig1s013ltr.pdf 4/22/2014
AP04/21/2014SLR39119013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022192s013lbl.pdf 4/22/2014
AP03/30/2015SCM       
AP05/26/2016SE846180015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s015ltr.pdf 5/27/2016
AP05/26/2016SE846224015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s015lbl.pdf 6/1/2016
AP03/29/2016SCM       
AP01/5/2016SLR44934017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022192Orig1s017ltr.pdf 1/6/2016
AP01/5/2016SLR44935017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022192s017lbl.pdf 1/6/2016




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