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FDA Drug Application 022318 by GENZYME

Application Number022318
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
AP08/12/2009N23197000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022318s000ltr.pdf 8/17/2009
AP08/12/2009N23518000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022318lbl.pdf 10/1/2009
AP08/12/2009N24575000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_renvela_toc.cfm 2/3/2011
AP08/12/2009N24576000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_SumR.pdf 2/3/2011
AP06/16/2011SLR29202003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.pdf 6/16/2011
AP06/16/2011SLR29252003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf 6/24/2011
AP011/26/2014SLR41112005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022127Orig1s011,022318Orig1s005ltr.pdf 11/28/2014
AP011/26/2014SLR41281005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf 12/17/2014
AP03/9/2016SLR45417006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s013,022318Orig1s006ltr.pdf 3/11/2016
AP03/9/2016SLR45437006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.pdf 3/14/2016




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