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FDA Drug Application 008316 by SANOFI AVENTIS US

Application Number008316
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/23/1952N       
AP09/11/1976SCM       
AP02/7/1977SLR       
AP05/15/1981SCP       
AP011/10/1986SPD       
AP010/30/1984SCM       
AP09/10/1985SLR       
AP010/28/1985SCS       
AP05/29/1990SCM       
AP09/23/1993SCM       
AP010/27/1993SCF       
AP06/11/2003SLR5942015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08316slr015ltr.pdf 6/22/2003
AP06/11/2003SLR6004015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08316slr015_primaquine_lbl.pdf 6/22/2003
AP07/28/2008SLR20608017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008316s017lbl.pdf 8/13/2008
AP07/28/2008SLR20610017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008316s017ltr.pdf 8/13/2008
AP04/16/2015SLR42558021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008316Orig1s021ltr.pdf 4/17/2015
AP04/16/2015SLR42565021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008316s021lbl.pdf 4/17/2015
AP07/27/2016SLR46666022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008316s022lbl.pdf 7/28/2016
AP07/27/2016SLR46679022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008316Orig1s022ltr.pdf 7/29/2016




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