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FDA Drug Application 021246 by ROCHE

Application Number	021246
Application Type	New Drug Application
Sponsor Applicant	ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Priority
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	0	12/14/2000	N	1515	000		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21246ltr.pdf	12/14/2000
AP	0	12/14/2000	N	1516	000		http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21246LBL.pdf	12/14/2000
AP	0	12/14/2000	N	7205	000		http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107838.htm	12/12/2003
AP	0	12/14/2000	N	9956	000		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-246_Tamiflu.cfm	8/9/2004
AP	0	7/24/2001	SLR	5557	001		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s1lbl.pdf	5/1/2003
AP	0	7/24/2001	SLR	16807	001		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm	6/22/2007
AP	0	7/5/2001	SCS	16821	002		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021246_S002_TamifluTOC.cfm	6/22/2007
AP	0	7/24/2001	SLR	5558	003		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21246s3lbl.pdf	5/1/2003
AP	0	7/24/2001	SLR	16810	003		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm	6/22/2007
AP	0	11/5/2001	SLR	5411	004		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf	4/22/2003
AP	0	11/5/2001	SLR	16812	004		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm	6/22/2007
AP	0	3/4/2002	SCS	16820	006		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021246_S006_TamifluTOC.cfm	6/22/2007
AP	0	4/26/2002	SLR	3349	007		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf	4/26/2002
AP	0	4/26/2002	SLR	3350	007		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf	4/26/2002
AP	0	4/26/2002	SLR	16815	007		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm	6/22/2007
AP	0	2/14/2003	SE4	23608	008		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf	10/16/2009
AP	0	6/24/2004	SLR	9687	010		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf	7/1/2004
AP	0	6/24/2004	SLR	9700	010		http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf	7/1/2004
AP	0	6/24/2004	SLR	16819	010		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm	6/22/2007
AP	0	4/26/2004	SO	23610	011		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf	10/19/2009
AP	0	8/12/2004	SCB	23612	012		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s019_021246s012ltr.pdf	10/19/2009
AP	0	10/19/2004	SCB	23613	013		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf	10/19/2009
AP	0	1/18/2005	SCM	23617	014		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf	10/19/2009
AP	0	5/19/2005	SCB	23618	016		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf	10/19/2009
AP	0	12/21/2005	SE5	13339	017		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf	1/5/2006
AP	0	12/21/2005	SE5	13370	017		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf	1/10/2006
AP	0	12/21/2005	SE5	13396	017		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf	1/18/2006
AP	0	12/21/2005	SE5	39762	017		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021246Orig1s017.pdf	7/7/2014
AP	0	10/14/2005	SCM	23621	018		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf	10/19/2009
AP	0	12/1/2005	SCM	23623	019		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf	10/19/2009
AP	0	6/23/2006	SCM	23625	020		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf	10/19/2009
AP	0	11/13/2006	SLR	15344	021		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021lbl.pdf	11/14/2006
AP	0	11/13/2006	SLR	15345	021		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021246s021ppi.pdf	11/14/2006
AP	0	11/13/2006	SLR	15362	021		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf	11/16/2006
AP	0	2/1/2007	SCM	23642	022		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf	10/21/2009
AP	0	12/14/2006	SCR	23639	023		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021246s023ltr.pdf	10/19/2009
AP	0	3/12/2007	SCB	23644	024		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf	10/21/2009
AP	0	3/22/2007	SCB	23648	025		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf	10/21/2009
AP	0	3/26/2007	SCM	23646	026		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf	10/21/2009
AP	0	7/2/2007	SCF	16946	027		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf	7/5/2007
AP	0	7/2/2007	SCF	16949	027		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf	7/5/2007
AP	0	7/2/2007	SCF	36185	027		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021246Orig1s027.pdf	6/3/2013
AP	0	10/5/2007	SLR	18195	028		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf	10/10/2007
AP	0	10/5/2007	SLR	18216	028		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf	10/10/2007
AP	0	1/17/2008	SLR	18889	030		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf	1/18/2008
AP	0	1/17/2008	SLR	18905	030		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf	1/18/2008
AP	0	12/15/2010	SLR	27293	031		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf	12/16/2010
AP	0	12/15/2010	SLR	27311	031		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf	12/21/2010
AP	0	2/23/2009	SCM	23640	032		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021246s032ltr.pdf	10/19/2009
AP	1	9/25/2008	SLR	22365	033		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf	4/30/2009
AP	1	9/25/2008	SLR	22366	033		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf	4/30/2009
AP	0	2/22/2010	SLR	24870	034		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf	2/26/2010
AP	0	2/22/2010	SLR	24930	034		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf	3/3/2010
AP	0	2/22/2010	SLR	43436	034		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s034.pdf	7/22/2015
AP	0	2/22/2010	SE2	24871	035		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf	2/26/2010
AP	0	2/22/2010	SE2	24931	035		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf	3/3/2010
AP	0	2/22/2010	SE2	43424	035		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021246Orig1s035.pdf	7/20/2015
AP	0	11/5/2010	SLR	26914	038		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021246s038lbl.pdf	11/5/2010
AP	0	11/5/2010	SLR	26922	038		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf	11/10/2010
AP	0	3/21/2011	SLR	28310	039		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf	3/23/2011
AP	0	3/21/2011	SLR	28334	039		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf	3/24/2011
AP	0	3/21/2011	SLR	36183	039		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021246Orig1s039.pdf	6/3/2013
AP	0	2/7/2011	SLR	27759	040		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021246s040lbl.pdf	2/7/2011
AP	0	2/7/2011	SLR	27794	040		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf	2/9/2011
AP	0	8/16/2012	SLR	33507	042		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf	8/17/2012
AP	0	8/16/2012	SLR	33514	042		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf	8/20/2012
AP	0	11/26/2014	SLR	41120	043		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf	11/28/2014
AP	0	11/26/2014	SLR	41135	043		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf	12/3/2014
AP	0	1/29/2013	S	34994	044		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf	1/29/2013
AP	0	1/29/2013	S	36773	044		http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf	8/12/2013
AP	0	1/29/2013	S	36780	044	Package Labeling	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044pkglbl.pdf	8/12/2013
AP	0	12/21/2012	SE5	34731	045		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021246s045lbl.pdf	12/21/2012
AP	0	12/21/2012	SE5	34734	045		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf	12/21/2012
AP	0	12/21/2012	SE5	34737	045		http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf	12/21/2012
AP	0	12/21/2012	SE5	35637	045		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm	4/8/2013
AP	0	2/7/2013	SCM
AP	0	5/30/2014	SLR	39426	047		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf	6/3/2014
AP	0	5/30/2014	SLR	39435	047		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf	6/3/2014
AP	0	10/14/2014	SLR	40777	048		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf	10/15/2014
AP	0	10/14/2014	SLR	40793	048		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf	10/16/2014
AP	0	3/16/2015	SCM
AP	0	6/20/2016	SLR	46390	051		http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf	6/21/2016
AP	0	6/20/2016	SLR	46398	051		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf	6/22/2016

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