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FDA Drug Application 201373 by SANOFI AVENTIS US

Application Number201373
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/24/2011N27674000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201373s000ltr.pdf 2/2/2011
AP01/24/2011N30229000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373_allegra_toc.cfm 10/7/2011
AP01/24/2011N30230000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373Orig1s000SumR.pdf 10/7/2011
AP01/24/2011N37925000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201373Orig1s000lbl.pdf 11/26/2013
AP02/23/2012SLR31912002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373s002ltr.pdf 2/27/2012
AP08/23/2012SLR33560004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373Orig1s004ltr.pdf 8/27/2012
AP04/28/2013SLR35891005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201373Orig1s005ltr.pdf 4/30/2013
AP04/28/2013SLR37313005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201373Orig1s005lbl.pdf 10/2/2013
AP06/15/2016SLR46357006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf 6/17/2016
AP06/15/2016SLR46368006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201373Orig1s006ltr.pdf 6/21/2016




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