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FDA Drug Application 022500 by TRIS PHARMA INC

Application Number022500
Application Type New Drug Application
Sponsor ApplicantTRIS PHARMA 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
AP012/3/2009N24249000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022500lbl.pdf 12/10/2009
AP012/3/2009N24253000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022499s000,022500s000ltr.pdf 12/11/2009
AP012/3/2009N25537000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022500_clonidine_toc.cfm 5/12/2010
AP012/3/2009N25538000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022500s000sumr.pdf 5/12/2010
AP09/23/2010SLR26563001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022499s001,022500s001ltr.pdf 9/29/2010
AP09/23/2010SLR26572001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022500s001lbl.pdf 9/29/2010




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