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FDA Drug Application 016131 by SANOFI AVENTIS US

Application Number016131
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/1/1967N       
AP06/23/1980SLR       
AP06/23/1980SCS       
AP011/18/1981SDS       
AP012/21/1993SLR       
AP04/27/1988SCP       
AP08/14/1991SCS       
AP02/22/1994SCM       
AP09/30/1994SLR       
AP010/25/1995SLR       
AP012/10/2002SCS       
AP010/22/2012SLR34167026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf 10/22/2012
AP010/22/2012SLR34168026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016131s026ltr.pdf 10/24/2012
AP010/22/2012SLR45076026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/016131Orig1s026.pdf 2/2/2016




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