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FDA Drug Application 021087 by ROCHE

Application Number021087
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
AP010/27/1999N1191000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21087LTR.PDF 10/27/1999
AP010/27/1999N1192000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf 10/27/1999
AP010/27/1999N3351000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21087_Tamiflu.cfm 5/29/2001
AP010/27/1999N15453000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107838.htm 12/13/2006
AP010/31/2000SCM16801001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S001_TamifluTOC.cfm 6/18/2007
AP011/17/2000SE11566002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21087s2.ltr.pdf 11/17/2000
AP011/17/2000SE11567002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf 11/17/2000
AP011/17/2000SE18339002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-087SE1-002_review.pdf 4/14/2004
AP011/9/2000SCE16802003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S003_TamifluTOC.cfm 6/18/2007
AP03/6/2001SCS16803004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S004_TamifluTOC.cfm 6/18/2007
AP07/24/2001SLR16805005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm 6/22/2007
AP07/24/2001SLR5605005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf 7/24/2001
AP07/24/2001SLR5606006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf 7/24/2001
AP07/24/2001SLR16806006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm 6/22/2007
AP07/13/2001SCE16808007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S007_TamifluTOC.cfm 6/22/2007
AP07/24/2001SLR16809008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm 6/22/2007
AP07/24/2001SLR5608008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s8lbl.pdf 7/24/2001
AP011/5/2001SLR5410009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf 4/22/2003
AP011/5/2001SLR16811009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm 6/22/2007
AP04/26/2002SLR16814010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm 6/22/2007
AP04/26/2002SLR3347010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf 4/26/2002
AP04/26/2002SLR3348010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf 4/26/2002
AP03/28/2002SCE16816011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S011_TamilfluTOC.cfm 6/22/2007
AP05/7/2002SCE16817012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S012_TamifluTOC.cfm 6/22/2007
AP03/10/2003SCB23735013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s013ltr.pdf 11/5/2009
AP02/14/2003SE423607014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf 10/16/2009
AP02/28/2003SCE23736015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s015ltr.pdf 11/5/2009
AP06/24/2004SLR9686016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf 7/1/2004
AP06/24/2004SLR9699016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf 7/1/2004
AP06/24/2004SLR16818016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm 6/22/2007
AP04/26/2004SCE23737017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s017ltr.pdf 11/5/2009
AP04/24/2004SO23611018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf 10/19/2009
AP08/12/2004SCB       
AP010/19/2004SCB23614020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf 10/19/2009
AP01/18/2005SCM23616021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf 10/19/2009
AP04/20/2005SCP11501023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s023ltr.pdf 4/28/2005
AP04/20/2005SCP11521023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s023lbl.pdf 4/28/2005
AP05/19/2005SCB23619024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf 10/19/2009
AP010/27/2005SLR12989025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf 11/1/2005
AP010/27/2005SLR13010025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s025ltr.pdf 11/1/2005
AP08/16/2005SLR12628026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s026ltr.pdf 8/19/2005
AP08/16/2005SLR12647026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf 8/19/2005
AP010/14/2005SCB23620027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s027ltr.pdf 10/19/2009
AP010/14/2005SCM23622028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf 10/19/2009
AP012/1/2005SCM23624029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf 10/19/2009
AP012/21/2005SE513369030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf 1/10/2006
AP012/21/2005SE513371030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf 1/10/2006
AP012/21/2005SE513397030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf 1/18/2006
AP012/21/2005SE539763030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021087Orig1s030.pdf 7/7/2014
AP06/23/2006SCM23626031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf 10/19/2009
AP011/13/2006SLR15343033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf 11/14/2006
AP011/13/2006SLR15346033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033ppi.pdf 11/14/2006
AP011/13/2006SLR15363033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf 11/16/2006
AP012/19/2006SCB23635034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s034ltr.pdf 10/19/2009
AP02/1/2007SCM23643035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf 10/21/2009
AP02/27/2007SCB23636036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s036ltr.pdf 10/19/2009
AP03/12/2007SCB23645037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf 10/21/2009
AP03/22/2007SCB23649038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf 10/21/2009
AP03/26/2007SCM23647039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf 10/21/2009
AP07/2/2007SCF36186040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021087Orig1s040.pdf 6/3/2013
AP07/2/2007SCF16947040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf 7/5/2007
AP07/2/2007SCF16948040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf 7/5/2007
AP010/5/2007SLR18194041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf 10/10/2007
AP010/5/2007SLR18215041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf 10/10/2007
AP01/17/2008SLR18888042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf 1/18/2008
AP01/17/2008SLR18904042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf 1/18/2008
AP05/5/2008SCB23637043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s043ltr.pdf 10/19/2009
AP012/3/2007SCE18665044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s044ltr.pdf 12/18/2007
AP012/15/2010SLR27294045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf 12/16/2010
AP012/15/2010SLR27310045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf 12/21/2010
AP06/10/2008SLR23638046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s046ltr.pdf 10/19/2009
AP09/25/2008SLR22362047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf 4/29/2009
AP09/25/2008SLR22363047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf 4/29/2009
AP02/22/2010SLR24868048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf 2/26/2010
AP02/22/2010SLR24932048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf 3/3/2010
AP02/22/2010SLR43427048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021087Orig1s048.pdf 7/21/2015
AP02/22/2010SE243422049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021087Orig1s049.pdf 7/20/2015
AP02/22/2010SE224933049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf 3/3/2010
AP02/22/2010SE224869049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf 2/26/2010
AP011/5/2010SLR26915055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf 11/5/2010
AP011/5/2010SLR26921055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf 11/10/2010
AP03/21/2011SLR28309056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf 3/23/2011
AP03/21/2011SLR28333056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf 3/24/2011
AP03/21/2011SLR36184056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021087Orig1s056.pdf 6/3/2013
AP02/7/2011SLR27760057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s057lbl.pdf 2/7/2011
AP02/7/2011SLR27793057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf 2/9/2011
AP08/16/2012SLR33506059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf 8/17/2012
AP08/16/2012SLR33513059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf 8/20/2012
AP011/26/2014SLR41119060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf 11/28/2014
AP011/26/2014SLR41134060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf 12/3/2014
AP01/29/2013S36772061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf 8/12/2013
AP01/29/2013S36779061Package Labeling  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044pkglbl.pdf 8/12/2013
AP01/29/2013S34995061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf 1/29/2013
AP012/21/2012SE535638062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm 4/8/2013
AP012/21/2012SE534733062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s062lbl.pdf 12/21/2012
AP012/21/2012SE534735062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf 12/21/2012
AP012/21/2012SE534736062   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf 12/21/2012
AP012/20/2013SCM       
AP05/30/2014SLR39425064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf 6/3/2014
AP05/30/2014SLR39436064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf 6/3/2014
AP010/14/2014SLR40778065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf 10/15/2014
AP010/14/2014SLR40792065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf 10/16/2014
AP010/8/2014SCM       
AP012/15/2014SCM       
AP06/20/2016SLR46389068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf 6/21/2016
AP06/20/2016SLR46397068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf 6/22/2016




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