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FDA Drug Application 204516 by SEBELA IRELAND LTD

Application Number204516
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND 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
AP06/28/2013N36409000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204516Orig1s000ltr.pdf 7/2/2013
AP06/28/2013N36520000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204516s000lbl.pdf 7/10/2013
AP06/28/2013N36596000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM362200.pdf 7/24/2013
AP06/28/2013N40004000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000TOC.cfm 7/25/2014
AP06/28/2013N40005000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204516Orig1s000SumR.pdf 7/25/2014
AP012/19/2013SCM       
AP04/1/2014SCM       
AP012/1/2014SLR41126003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204516Orig1s003ltr.pdf 12/2/2014
AP012/1/2014SLR41136003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204516s003lbl.pdf 12/3/2014




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