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FDA Drug Application 103749 by HOFFMAN-LA ROCHE

Application Number103749
Application Type Biologic License Application
Sponsor ApplicantHOFFMAN-LA ROCHE
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
AP012/10/1997N81740000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/daclhof121097L.htm 3/30/2004
AP012/10/1997N81750000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/daclhof121097lab.pdf 3/30/2004
AP012/10/1997N81760000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093377.htm 3/30/2004
AP07/29/2002S81785006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/daclhof072902L.pdf 3/30/2004
AP07/29/2002S81795006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/daclhof072902LB.pdf 3/30/2004
AP09/15/2005S154035059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103749s5059lbl.pdf 11/28/2006
AP09/15/2005S154265059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103749s5059ltr.pdf 12/4/2006




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