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FDA Drug Application 205677 by VANDA PHARMS INC

Application Number205677
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/31/2014N38419000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbledt.pdf 1/31/2014
AP01/31/2014N38420000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s000ltr.pdf 2/3/2014
AP01/31/2014N38712000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000TOC.cfm 3/7/2014
AP01/31/2014N38713000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000SumR.pdf 3/7/2014
AP01/31/2014N40712000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbl.pdf 10/3/2014
AP110/2/2014N38419000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbledt.pdf 1/31/2014
AP110/2/2014N38420000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s000ltr.pdf 2/3/2014
AP110/2/2014N38712000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000TOC.cfm 3/7/2014
AP110/2/2014N38713000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000SumR.pdf 3/7/2014
AP110/2/2014N40712000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s000lbl.pdf 10/3/2014
AP012/12/2014SLR41261001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205677Orig1s001ltr.pdf 12/16/2014
AP012/12/2014SLR41272001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205677s001lbl.pdf 12/16/2014
AP04/11/2016SCM       




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