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FDA Drug Application 022404 by MIDATECH PHARMA US

Application Number022404
Application Type New Drug Application
Sponsor ApplicantMIDATECH PHARMA US
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
AP04/16/2010N25438000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022404lbl.pdf 5/3/2010
AP04/16/2010N25449000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022404s000ltr.pdf 5/3/2010
AP04/16/2010N27360000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404s000_oravig_toc.cfm 12/23/2010
AP04/16/2010N27361000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404Orig1s000SumR.pdf 12/23/2010
AP04/8/2011SLR28506002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022404s002lbl.pdf 4/11/2011
AP04/8/2011SLR28539002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022404s002ltr.pdf 4/13/2011
AP03/5/2013SLR35348003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022404Orig1s003ltr.pdf 3/6/2013
AP03/5/2013SLR35390003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022404s003lbl.pdf 3/8/2013




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