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FDA Drug Application 021481 by ROCHE

Application Number021481
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/13/2003N4369000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021481lbl.pdf 3/18/2003
AP03/13/2003N4435000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21481ltr.pdf 3/20/2003
AP03/13/2003N6129000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021481_fuzeon_review.cfm 7/23/2003
AP010/15/2004SE710423002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21481s002lbl.pdf 10/18/2004
AP010/15/2004SE710424002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21481s002ltr.pdf 10/18/2004
AP06/29/2005SLR11941006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s006lbl.pdf 7/7/2005
AP06/29/2005SLR11957006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021481s006ltr.pdf 7/8/2005
AP08/12/2005SLR12603007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s007lbl.pdf 8/15/2005
AP08/12/2005SLR12613007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021481s007ltr.pdf 8/16/2005
AP09/29/2006SE815029010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s010lbl.pdf 10/2/2006
AP09/29/2006SE815033010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021481s010LTR.pdf 10/2/2006
AP01/19/2007SLR15698011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021481s011lbl.pdf 1/24/2007
AP01/19/2007SLR15704011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021481s011ltr.pdf 1/25/2007
AP012/20/2006SLR15516012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s012lbl.pdf 12/28/2006
AP012/20/2006SLR15521012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021481s012ltr.pdf 12/28/2006
AP012/16/2008SLR21397015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021481s015ltr.pdf 12/24/2008
AP012/22/2009SLR24383017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021481s017ltr.pdf 12/31/2009
AP012/22/2009SLR24395017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021481s017lbl.pdf 1/4/2010
AP04/28/2011SE828653020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021481s020lbl.pdf 4/29/2011
AP04/28/2011SE828677020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021481s020ltr.pdf 5/3/2011
AP09/22/2014SCM       
AP08/10/2012SLR33436025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021481Orig1s025ltr.pdf 8/15/2012
AP08/10/2012SLR33537025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021481s025lbl.pdf 8/22/2012
AP03/13/2013SCM       
AP010/31/2013SLR37676027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021481s027lbl.pdf 11/1/2013
AP010/31/2013SLR37707027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021481Orig1s027ltr.pdf 11/6/2013
AP06/19/2015SCM       
AP012/2/2015SLR44662030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021481Orig1s030ltr.pdf 12/3/2015
AP012/2/2015SLR44692030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021481s030lbl.pdf 12/8/2015




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