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FDA Drug Application 021179 by GENZYME

Application Number021179
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
AP07/12/2000N7913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-179_Renagel.cfm 3/11/2004
AP07/12/2000N1397000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21179ltr.pdf 7/12/2000
AP07/12/2000N1398000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21179lbl.pdf 7/12/2000
AP03/15/2002SCS       
AP02/6/2004SE17803002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-006,21179se1-002ltr.pdf 3/3/2004
AP01/7/2003SCM       
AP07/25/2005SLR12270015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021179s015ltr.pdf 7/26/2005
AP010/19/2007SE818250020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s020ltr.pdf 10/22/2007
AP010/19/2007SE818255020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s020lbl.pdf 10/22/2007
AP08/14/2007SLR17643021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s021lbl.pdf 8/17/2007
AP08/14/2007SLR17652021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s021LTR.pdf 8/17/2007
AP06/16/2011SLR29201029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021179s029lbl.pdf 6/16/2011
AP06/16/2011SLR29250029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf 6/24/2011
AP011/26/2014SLR41113030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021179Orig1s030ltr.pdf 11/28/2014
AP011/26/2014SLR41318030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021179Orig1s030lbl.pdf 12/19/2014
AP06/9/2015SCM       
AP03/9/2016SLR45420032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021179Orig1s032ltr.pdf 3/11/2016
AP03/9/2016SLR45427032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021179s032lbl.pdf 3/14/2016




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