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FDA Drug Application 125151 by SHIRE

Application Number125151
Application Type Biologic License Application
Sponsor ApplicantSHIRE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/24/2006N149960000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125151s0000_ElapraseTOC.cfm 9/26/2006
AP07/24/2006N150470000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125151s0000_Ltr.pdf 10/5/2006
AP011/24/2007S183840032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125151s032ltr.pdf 11/8/2007
AP011/24/2007S184160032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125151s032lbl.pdf 11/13/2007
AP06/24/2013SE8363720152   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0152lbl.pdf 6/24/2013
AP06/24/2013SE8363860152   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184ltr.pdf 6/26/2013
AP06/24/2013SE8363870184   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125151Orig1s152,s184ltr.pdf 6/26/2013
AP06/24/2013SE8363730184   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125151s0184lbl.pdf 6/24/2013




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