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FDA Drug Application 022278 by DORC

Application Number022278
Application Type New Drug Application
Sponsor ApplicantDORC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/2009N21902000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022278s000ltr.pdf 2/24/2009
AP02/20/2009N21909000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022278lbl.pdf 2/24/2009
AP02/20/2009N24293000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022278_membraneblue_toc.cfm 12/16/2009
AP08/25/2014SCM       
AP09/15/2014SLR40506003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022278Orig1s003ltr.pdf 9/17/2014
AP09/15/2014SLR40522003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022278s003lbl.pdf 9/19/2014




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