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FDA Drug Application 103846 by ELAN PHARM

Application Number103846
Application Type Biologic License Application
Sponsor ApplicantELAN PHARM
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
AP012/8/2000N79810000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/botelan120800L.htm 3/17/2004
AP012/8/2000N79820000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/botelan120800lb.pdf 3/17/2004
AP012/8/2000N79830000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080661.htm 3/17/2004
AP012/8/2000N205880000   http://wcms.fda.gov/FDAgov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm175011.htm 8/12/2008
AP08/5/2009SLR231505120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103846s5120ltr.pdf 8/7/2009
AP08/5/2009SLR231515120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120lbl.pdf 8/7/2009
AP08/5/2009SLR231525120   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103846s5120Medguide.pdf 8/7/2009
AP06/13/2012S329135156   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103846s5156ltr.pdf 6/15/2012




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