Back to FDA Applications sponsored by ROCHE

FDA Drug Application 021246 by ROCHE

Application Number021246
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/14/2000N1515000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21246ltr.pdf 12/14/2000
AP012/14/2000N1516000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21246LBL.pdf 12/14/2000
AP012/14/2000N7205000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107838.htm 12/12/2003
AP012/14/2000N9956000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-246_Tamiflu.cfm 8/9/2004
AP07/24/2001SLR16807001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm 6/22/2007
AP07/24/2001SLR5557001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s1lbl.pdf 5/1/2003
AP07/5/2001SCS16821002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021246_S002_TamifluTOC.cfm 6/22/2007
AP07/24/2001SLR5558003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s3lbl.pdf 5/1/2003
AP07/24/2001SLR16810003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm 6/22/2007
AP011/5/2001SLR16812004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm 6/22/2007
AP011/5/2001SLR5411004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf 4/22/2003
AP03/4/2002SCS16820006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021246_S006_TamifluTOC.cfm 6/22/2007
AP04/26/2002SLR16815007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm 6/22/2007
AP04/26/2002SLR3349007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf 4/26/2002
AP04/26/2002SLR3350007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf 4/26/2002
AP02/14/2003SE423608008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf 10/16/2009
AP06/24/2004SLR9687010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf 7/1/2004
AP06/24/2004SLR9700010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf 7/1/2004
AP06/24/2004SLR16819010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm 6/22/2007
AP04/26/2004SO23610011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf 10/19/2009
AP08/12/2004SCB23612012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s019_021246s012ltr.pdf 10/19/2009
AP010/19/2004SCB23613013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf 10/19/2009
AP01/18/2005SCM23617014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf 10/19/2009
AP05/19/2005SCB23618016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf 10/19/2009
AP012/21/2005SE513339017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf 1/5/2006
AP012/21/2005SE513370017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf 1/10/2006
AP012/21/2005SE513396017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf 1/18/2006
AP012/21/2005SE539762017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021246Orig1s017.pdf 7/7/2014
AP010/14/2005SCM23621018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf 10/19/2009
AP012/1/2005SCM23623019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf 10/19/2009
AP06/23/2006SCM23625020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf 10/19/2009
AP011/13/2006SLR15344021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021lbl.pdf 11/14/2006
AP011/13/2006SLR15345021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021ppi.pdf 11/14/2006
AP011/13/2006SLR15362021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf 11/16/2006
AP02/1/2007SCM23642022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf 10/21/2009
AP012/14/2006SCR23639023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021246s023ltr.pdf 10/19/2009
AP03/12/2007SCB23644024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf 10/21/2009
AP03/22/2007SCB23648025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf 10/21/2009
AP03/26/2007SCM23646026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf 10/21/2009
AP07/2/2007SCF36185027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021246Orig1s027.pdf 6/3/2013
AP07/2/2007SCF16946027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf 7/5/2007
AP07/2/2007SCF16949027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf 7/5/2007
AP010/5/2007SLR18195028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf 10/10/2007
AP010/5/2007SLR18216028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf 10/10/2007
AP01/17/2008SLR18889030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf 1/18/2008
AP01/17/2008SLR18905030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf 1/18/2008
AP012/15/2010SLR27293031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf 12/16/2010
AP012/15/2010SLR27311031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf 12/21/2010
AP02/23/2009SCM23640032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021246s032ltr.pdf 10/19/2009
AP19/25/2008SLR22365033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf 4/30/2009
AP19/25/2008SLR22366033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf 4/30/2009
AP02/22/2010SLR24930034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf 3/3/2010
AP02/22/2010SLR24870034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf 2/26/2010
AP02/22/2010SLR43436034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s034.pdf 7/22/2015
AP02/22/2010SE243424035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s035.pdf 7/20/2015
AP02/22/2010SE224871035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf 2/26/2010
AP02/22/2010SE224931035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf 3/3/2010
AP011/5/2010SLR26914038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021246s038lbl.pdf 11/5/2010
AP011/5/2010SLR26922038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf 11/10/2010
AP03/21/2011SLR28310039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf 3/23/2011
AP03/21/2011SLR28334039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf 3/24/2011
AP03/21/2011SLR36183039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021246Orig1s039.pdf 6/3/2013
AP02/7/2011SLR27759040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021246s040lbl.pdf 2/7/2011
AP02/7/2011SLR27794040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf 2/9/2011
AP08/16/2012SLR33507042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf 8/17/2012
AP08/16/2012SLR33514042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf 8/20/2012
AP011/26/2014SLR41120043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf 11/28/2014
AP011/26/2014SLR41135043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf 12/3/2014
AP01/29/2013S34994044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf 1/29/2013
AP01/29/2013S36773044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf 8/12/2013
AP01/29/2013S36780044Package Labeling  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044pkglbl.pdf 8/12/2013
AP012/21/2012SE535637045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm 4/8/2013
AP012/21/2012SE534731045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021246s045lbl.pdf 12/21/2012
AP012/21/2012SE534734045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf 12/21/2012
AP012/21/2012SE534737045   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf 12/21/2012
AP02/7/2013SCM       
AP05/30/2014SLR39426047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf 6/3/2014
AP05/30/2014SLR39435047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf 6/3/2014
AP010/14/2014SLR40777048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf 10/15/2014
AP010/14/2014SLR40793048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf 10/16/2014
AP03/16/2015SCM       
AP06/20/2016SLR46390051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf 6/21/2016
AP06/20/2016SLR46398051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf 6/22/2016




Back to FDA Applications sponsored by ROCHE