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FDA Drug Application 021818 by ROMARK

Application Number021818
Application Type New Drug Application
Sponsor ApplicantROMARK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/16/2005N11829000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021818lbl.pdf 6/16/2005
AP06/16/2005N11838000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021818ltr.pdf 6/21/2005
AP06/16/2005N18116000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021818s000_021498s003TOC.cfm 10/2/2007




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