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FDA Drug Application 103946 by SANOFI SYNTHELABO

Application Number103946
Application Type Biologic License Application
Sponsor ApplicantSANOFI SYNTHELABO
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
AP07/12/2002N79220000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080525.htm 3/12/2004
AP07/12/2002N79230000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/rasbsan071202L.htm 3/12/2004
AP07/12/2002N79240000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/rasbsan071202LB.pdf 3/12/2004
AP012/15/2004S110195017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103946_5017ltr.pdf 1/26/2005
AP012/15/2004S110365017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103946_5017lbl.pdf 1/26/2005
AP09/10/2007S       
AP09/10/2007S181785049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103946s5049ltr.pdf 10/4/2007
AP09/10/2007S181795049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103946s5049lbl.pdf 10/4/2007
AP010/16/2009S236155083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103946s5083lbl.pdf 10/19/2009
AP010/16/2009S236785083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103946s5083ltr.pdf 10/26/2009
AP02/3/2015SLR418235094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5094ltr.pdf 2/12/2015
AP05/22/2015SLR428985095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103946Orig1s5095ltr.pdf 5/26/2015
AP05/22/2015SLR429025095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103946s5095lbl.pdf 5/27/2015
AP06/13/2016SLR463325097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103946Orig1s5097ltr.pdf 6/15/2016
AP06/13/2016SLR463535097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103946s5097lbl.pdf 6/17/2016




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