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FDA Drug Application 021024 by SANOFI AVENTIS US

Application Number021024
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/22/1998N936000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/21024ltr.pdf 6/22/1998
AP06/22/1998N937000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/21024.cfm 6/22/1998
AP06/22/1998N938000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21024lbl.pdf 6/22/1998
AP04/21/1999SCS       
AP07/22/1999SCE       
AP012/10/1999SCP       
AP09/13/2000SLR       
AP010/20/2000SE73889005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024S5_Priftin.cfm 10/20/2000
AP010/20/2000SE74995005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_Approv.pdf 10/20/2000
AP010/20/2000SE74996005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21024s5_Priftin_prntlbl.pdf 10/20/2000
AP012/12/2000SCS       
AP06/1/2009SE736182008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021024Orig1s008.pdf 6/3/2013
AP06/1/2009SE722674008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021024s008ltr.pdf 6/2/2009
AP06/1/2009SE722680008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021024s008lbl.pdf 6/3/2009
AP07/30/2010SLR26119009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021024s009ltr.pdf 8/9/2010
AP07/30/2010SLR26238009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021024s009lbl.pdf 7/30/2010
AP011/20/2014SLR41069010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s010ltr.pdf 11/24/2014
AP011/25/2014SE841090011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021024Orig1s011ltr.pdf 11/26/2014
AP011/25/2014SE841141011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021024s011lbl.pdf 12/3/2014
AP011/25/2014SE841208011   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426514.pdf 12/11/2014
AP08/7/2015SCM       
AP07/1/2015SLR43278013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021024Orig1s013ltr.pdf 7/8/2015
AP07/1/2015SLR43456013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021024s013lbl.pdf 7/23/2015




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