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FDA Drug Application 022127 by GENZYME

Application Number022127
Application Type New Drug Application
Sponsor ApplicantGENZYME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/19/2007N18256000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022127lbl.pdf 10/22/2007
AP010/19/2007N18263000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022127s000ltr.pdf 10/22/2007
AP010/19/2007N20716000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022127s000TOC.cfm 8/29/2008
AP010/19/2007N20717000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022127s000_SumR.pdf 8/29/2008
AP06/16/2011SLR29203008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.pdf 6/16/2011
AP06/16/2011SLR29251008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf 6/24/2011
AP011/26/2014SLR41111011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022127Orig1s011,022318Orig1s005ltr.pdf 11/28/2014
AP011/26/2014SLR41282011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf 12/17/2014
AP03/9/2016SLR45416013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s013,022318Orig1s006ltr.pdf 3/11/2016
AP03/9/2016SLR45438013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.pdf 3/14/2016




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