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FDA Drug Application 022425 by SANOFI AVENTIS US

Application Number022425
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
AP07/1/2009N22870000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf 7/6/2009
AP07/1/2009N23090000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022425s000ltr.pdf 7/30/2009
AP07/1/2009N23208000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000TOC.cfm 8/20/2009
AP07/1/2009N23209000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_SumR.pdf 8/20/2009
AP07/1/2009N24020000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM171764.pdf 11/19/2009
AP02/11/2011SLR27842001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s001ltr.pdf 2/15/2011
AP02/11/2011SLR27944001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s001lbl.pdf 2/24/2011
AP01/25/2012SLR31583002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s002ltr.pdf 1/30/2012
AP01/25/2012SLR31611002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s002lbl.pdf 1/31/2012
AP01/31/2011SLR27666004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s004lbl.pdf 1/31/2011
AP01/31/2011SLR27721004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s004ltr.pdf 2/4/2011
AP02/11/2011SLR27838005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s005ltr.pdf 2/15/2011
AP08/5/2011S29738006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s006ltr.pdf 8/11/2011
AP03/11/2011SLR28221007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s007lbl.pdf 3/11/2011
AP03/11/2011SLR28237007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s007ltr.pdf 3/14/2011
AP06/21/2011SLR29288010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s010ltr.pdf 6/27/2011
AP06/21/2011SLR29319010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s010lbl.pdf 6/29/2011
AP08/22/2011SLR29953012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s012ltr.pdf 9/6/2011
AP08/22/2011SLR29959012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s012lbl.pdf 9/7/2011
AP012/19/2011SLR31017013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s013lbl.pdf 12/19/2011
AP012/19/2011SLR31161013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022425s013ltr.pdf 12/21/2011
AP06/13/2012SLR32912014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425s014ltr.pdf 6/15/2012
AP06/13/2012SLR32933014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s014lbl.pdf 6/18/2012
AP09/7/2012SLR33686016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf 9/10/2012
AP09/7/2012SLR33700016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf 9/11/2012
AP09/7/2012SLR33703016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018mg.pdf 9/11/2012
AP09/7/2012SE833687017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf 9/10/2012
AP09/7/2012SE833701017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf 9/11/2012
AP09/7/2012SE833704017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018mg.pdf 9/11/2012
AP09/7/2012SLR33688018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022425Orig1s016,s017,s018ltr.pdf 9/10/2012
AP09/7/2012SLR33702018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018lbl.pdf 9/11/2012
AP09/7/2012SLR33705018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022425s016s017s018mg.pdf 9/11/2012
AP03/27/2013SLR35566021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022425Orig1s021ltr.pdf 3/29/2013
AP03/27/2013SLR35603021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022425s021lbl.pdf 4/1/2013
AP03/19/2014SLR38853022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s022ltr.pdf 3/20/2014
AP01/30/2014SLR38403023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s023lbl.pdf 1/31/2014
AP01/30/2014SLR38435023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s023ltr.pdf 2/4/2014
AP03/19/2014SLR       
AP03/31/2014SLR38961025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s025ltr.pdf 4/3/2014
AP03/31/2014SLR39595025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf 6/23/2014
AP03/19/2014SCM       
AP02/12/2016S45167027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022425Orig1s027ltr.pdf 2/16/2016




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