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FDA Drug Application 020898 by GENZYME

Application Number020898
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
AP011/30/1998N539000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20898ltr.pdf 11/30/1998
AP011/30/1998N3905000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen.cfm 6/19/2001
AP011/30/1998N5118000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20898_Thyrogen_prntlbl.pdf 11/30/1998
AP09/3/1999SCM       
AP09/2/1999SCS       
AP011/16/1999SCS       
AP05/25/2000SCS       
AP010/26/2001SLR       
AP02/28/2001SCS       
AP03/1/2001SCS       
AP03/1/2001SCS       
AP03/15/2001SCS       
AP06/13/2001SCS       
AP09/17/2001SCM       
AP06/25/2002SCS       
AP010/8/2002SCM       
AP03/11/2004SLR7949021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20898slr021ltr.pdf 3/16/2004
AP03/11/2004SLR8243021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20898slr021_Thyrogen_lbl.pdf 4/5/2004
AP012/14/2007SE118689029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020898s029lbl.pdf 12/27/2007
AP012/14/2007SE118830029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020898s029ltr.pdf 1/9/2008
AP01/24/2006SE813494031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020898s031lbl.pdf 1/25/2006
AP01/24/2006SE813545031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020898s031ltr.pdf 1/30/2006
AP08/12/2008SLR20615038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020898s038ltr.pdf 8/19/2008
AP08/12/2008SLR20711038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020898s038lbl.pdf 8/29/2008
AP07/27/2012SLR33319051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020898Orig1s051ltr.pdf 7/31/2012
AP07/27/2012SLR33324051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020898s051lbl.pdf 7/31/2012
AP012/14/2012SCM       
AP03/21/2014SE838874054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020898Orig1s054ltr.pdf 3/24/2014
AP03/21/2014SE838893054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020898s054lbl.pdf 3/25/2014
AP05/7/2013SCM       
AP06/12/2013SCM       
AP08/15/2016SCM       
AP010/6/2016SCM       




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