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FDA Drug Application 021673 by GENZYME

Application Number021673
Application Type New Drug Application
Sponsor ApplicantGENZYME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/2004N10804000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf 12/29/2004
AP012/28/2004N10805000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021673ltr.pdf 12/29/2004
AP012/28/2004N11342000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-673_Clolar.cfm 4/5/2005
AP010/17/2008SE821055005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf 10/23/2008
AP010/17/2008SLR21054007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf 10/23/2008
AP06/10/2011SLR29120010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf 6/14/2011
AP06/10/2011SLR29143010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021673s010ltr.pdf 6/15/2011
AP01/10/2013SLR34877022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf 1/11/2013
AP01/10/2013SLR34880022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021673Orig1s022ltr.pdf 1/14/2013
AP09/15/2014SLR40508023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021673Orig1s023ltr.pdf 9/17/2014
AP09/15/2014SLR40521023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf 9/19/2014
AP012/16/2015SLR44810024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf 12/17/2015
AP012/16/2015SLR44824024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021673Orig1s024ltr.pdf 12/18/2015
AP010/27/2016SLR47539025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021673Orig1s025ltr.pdf 10/31/2016




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