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FDA Drug Application 050813 by VERNALIS R AND D LTD

Application Number050813
Application Type New Drug Application
Sponsor ApplicantVERNALIS R AND D LTD
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
AP01/23/2008N18948000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050813lbl.pdf 1/24/2008
AP01/23/2008N18957000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050813s000ltr.pdf 1/25/2008
AP01/23/2008N25131000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813_moxatag_toc.cfm 3/26/2010
AP01/23/2008N25132000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050813s000sumr.pdf 3/26/2010
AP06/9/2015SLR43036003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050813Orig1s003ltr.pdf 6/10/2015
AP06/9/2015SLR43042003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050813s003lbl.pdf 6/11/2015




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