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FDA Drug Application 022524 by MIDATECH PHARMA US

Application Number022524
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
AP07/2/2010N25951000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022524s000lbl.pdf 7/12/2010
AP07/2/2010N26016000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022524s000ltr.pdf 7/27/2010
AP07/2/2010N28797000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524_zuplenz_toc.cfm 5/13/2011
AP07/2/2010N28798000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022524Orig1s000SumR.pdf 5/13/2011
AP010/30/2013SLR37626002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022524Orig1s002ltr.pdf 10/31/2013
AP010/30/2013SLR37636002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf 10/31/2013
AP09/18/2014SLR40533003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf 9/22/2014
AP09/18/2014SLR40563003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022524Orig1s003ltr.pdf 9/23/2014
AP06/25/2015SCM       




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