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FDA Drug Application 125274 by IPSEN BIOPHARM LTD

Application Number125274
Application Type Biologic License Application
Sponsor ApplicantIPSEN BIOPHARM LTD
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
AP04/29/2009N22448000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125274s000,125274s001ltr.pdf 5/7/2009
AP04/29/2009N22681000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf 6/4/2009
AP04/29/2009N22732000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s000_SumR.pdf 8/17/2011
AP04/29/2009N23950000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM165110.pdf 11/18/2009
AP04/29/2009N35636000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm175011.htm 4/5/2013
AP04/29/2009N22729000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s000_dysport_toc.cfm 8/17/2011
AP04/29/2009S22730001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274s001_dysport_toc.cfm 8/17/2011
AP04/29/2009S22731001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125274Orig1s001SumR.pdf 8/17/2011
AP04/29/2009S22682001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125274s0000s0001lbl.pdf 6/4/2009
AP04/29/2009S22449001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125274s000s001 ltr.pdf 5/7/2009
AP05/22/2012S327510052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125274s0052ltr.pdf 5/23/2012
AP05/22/2012S327530052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125274s0052lbl.pdf 5/23/2012
AP05/22/2012S327540052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125274s0052mg.pdf 5/23/2012
AP07/15/2015SE843392102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125274Orig1s102ltr.pdf 7/16/2015
AP07/15/2015SE843398102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125274s102lbl.pdf 7/16/2015
AP07/29/2016SE846697105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s105lbl.pdf 8/2/2016
AP07/29/2016SE846709105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125274Orig1s105ltr.pdf 8/2/2016




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