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FDA Drug Application 021087 by ROCHE

Application Number	021087
Application Type	New Drug Application
Sponsor Applicant	ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	10/27/1999	N	1191	000		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21087LTR.PDF	10/27/1999
AP	10/27/1999	N	1192	000		http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf	10/27/1999
AP	10/27/1999	N	3351	000		http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21087_Tamiflu.cfm	5/29/2001
AP	10/27/1999	N	15453	000		http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107838.htm	12/13/2006
AP	10/31/2000	SCM	16801	001		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S001_TamifluTOC.cfm	6/18/2007
AP	11/17/2000	SE1	1566	002		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21087s2.ltr.pdf	11/17/2000
AP	11/17/2000	SE1	1567	002		http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf	11/17/2000
AP	11/17/2000	SE1	8339	002		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-087SE1-002_review.pdf	4/14/2004
AP	11/9/2000	SCE	16802	003		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021087_S003_TamifluTOC.cfm	6/18/2007
AP	3/6/2001	SCS	16803	004		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S004_TamifluTOC.cfm	6/18/2007
AP	7/24/2001	SLR	5605	005		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf	7/24/2001
AP	7/24/2001	SLR	16805	005		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm	6/22/2007
AP	7/24/2001	SLR	5606	006		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s5s6lbl.pdf	7/24/2001
AP	7/24/2001	SLR	16806	006		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_s005s006_021246s001_TamifluTOC.cfm	6/22/2007
AP	7/13/2001	SCE	16808	007		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S007_TamifluTOC.cfm	6/22/2007
AP	7/24/2001	SLR	5608	008		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s8lbl.pdf	7/24/2001
AP	7/24/2001	SLR	16809	008		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S008_021246s003_TamifluTOC.cfm	6/22/2007
AP	11/5/2001	SLR	5410	009		http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21087s9lbl.pdf	4/22/2003
AP	11/5/2001	SLR	16811	009		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021087_S009_021246s004TamifluTOC.cfm	6/22/2007
AP	4/26/2002	SLR	3347	010		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21087s010update.pdf	4/26/2002
AP	4/26/2002	SLR	3348	010		http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21087S10lbl_update.pdf	4/26/2002
AP	4/26/2002	SLR	16814	010		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S010_021246s007_TamifluTOC.cfm	6/22/2007
AP	3/28/2002	SCE	16816	011		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S011_TamilfluTOC.cfm	6/22/2007
AP	5/7/2002	SCE	16817	012		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021087_S012_TamifluTOC.cfm	6/22/2007
AP	3/10/2003	SCB	23735	013		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s013ltr.pdf	11/5/2009
AP	2/14/2003	SE4	23607	014		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s014_021246s008ltr.pdf	10/16/2009
AP	2/28/2003	SCE	23736	015		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/021087s015ltr.pdf	11/5/2009
AP	6/24/2004	SLR	9686	016		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21087slr016,21246slr010ltr.pdf	7/1/2004
AP	6/24/2004	SLR	9699	016		http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21087slr016,21246slr010_Tamiflu_lbl.pdf	7/1/2004
AP	6/24/2004	SLR	16818	016		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021087_S016_021246s010TamifluTOC.cfm	6/22/2007
AP	4/26/2004	SCE	23737	017		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s017ltr.pdf	11/5/2009
AP	4/24/2004	SO	23611	018		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s018_021246s011ltr.pdf	10/19/2009
AP	8/12/2004	SCB
AP	10/19/2004	SCB	23614	020		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021087s020_021246s013ltr.pdf	10/19/2009
AP	1/18/2005	SCM	23616	021		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s021_021246s014ltr.pdf	10/19/2009
AP	4/20/2005	SCP	11501	023		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s023ltr.pdf	4/28/2005
AP	4/20/2005	SCP	11521	023		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s023lbl.pdf	4/28/2005
AP	5/19/2005	SCB	23619	024		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s024_021246s016ltr.pdf	10/19/2009
AP	10/27/2005	SLR	12989	025		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s025lbl.pdf	11/1/2005
AP	10/27/2005	SLR	13010	025		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s025ltr.pdf	11/1/2005
AP	8/16/2005	SLR	12628	026		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s026ltr.pdf	8/19/2005
AP	8/16/2005	SLR	12647	026		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021087s026lbl.pdf	8/19/2005
AP	10/14/2005	SCB	23620	027		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s027ltr.pdf	10/19/2009
AP	10/14/2005	SCM	23622	028		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s028_021246s018ltr.pdf	10/19/2009
AP	12/1/2005	SCM	23624	029		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021087s029_021246s019ltr.pdf	10/19/2009
AP	12/21/2005	SE5	13369	030		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017_021087s030lbl.pdf	1/10/2006
AP	12/21/2005	SE5	13371	030		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021246s017,021087s30ppi.pdf	1/10/2006
AP	12/21/2005	SE5	13397	030		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021246s017,021087s030rev2.pdf	1/18/2006
AP	12/21/2005	SE5	39763	030		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021087Orig1s030.pdf	7/7/2014
AP	6/23/2006	SCM	23626	031		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s031_021246s020ltr.pdf	10/19/2009
AP	11/13/2006	SLR	15343	033		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033lbl.pdf	11/14/2006
AP	11/13/2006	SLR	15346	033		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021087s033ppi.pdf	11/14/2006
AP	11/13/2006	SLR	15363	033		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s033, 021246s021LTR.pdf	11/16/2006
AP	12/19/2006	SCB	23635	034		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021087s034ltr.pdf	10/19/2009
AP	2/1/2007	SCM	23643	035		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s035_021246s022ltr.pdf	10/21/2009
AP	2/27/2007	SCB	23636	036		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s036ltr.pdf	10/19/2009
AP	3/12/2007	SCB	23645	037		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s037_021246s024ltr.pdf	10/21/2009
AP	3/22/2007	SCB	23649	038		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021246s025_021087s038ltr.pdf	10/21/2009
AP	3/26/2007	SCM	23647	039		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s039_021246s026ltr.pdf	10/21/2009
AP	7/2/2007	SCF	16947	040		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s040, 021246s027_LTR.pdf	7/5/2007
AP	7/2/2007	SCF	16948	040		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s040, 021246s027_LBL.pdf	7/5/2007
AP	7/2/2007	SCF	36186	040		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021087Orig1s040.pdf	6/3/2013
AP	10/5/2007	SLR	18194	041		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s041, 021246s028ltr.pdf	10/10/2007
AP	10/5/2007	SLR	18215	041		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021087s041,021246s028lbl.pdf	10/10/2007
AP	1/17/2008	SLR	18888	042		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s042,021246s030lbl.pdf	1/18/2008
AP	1/17/2008	SLR	18904	042		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s042,021246s030ltr.pdf	1/18/2008
AP	5/5/2008	SCB	23637	043		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s043ltr.pdf	10/19/2009
AP	12/3/2007	SCE	18665	044		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021087s044ltr.pdf	12/18/2007
AP	12/15/2010	SLR	27294	045		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s045,021246s031lbl.pdf	12/16/2010
AP	12/15/2010	SLR	27310	045		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s045,021246s031ltr.pdf	12/21/2010
AP	6/10/2008	SLR	23638	046		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s046ltr.pdf	10/19/2009
AP	9/25/2008	SLR	22362	047		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021087s047,021246s033ltr.pdf	4/29/2009
AP	9/25/2008	SLR	22363	047		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021087s047, 021246s033lbl.pdf	4/29/2009
AP	2/22/2010	SLR	24868	048		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf	2/26/2010
AP	2/22/2010	SLR	24932	048		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf	3/3/2010
AP	2/22/2010	SLR	43427	048		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021087Orig1s048.pdf	7/21/2015
AP	2/22/2010	SE2	24869	049		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s048s049,021246s034s035ltr.pdf	2/26/2010
AP	2/22/2010	SE2	24933	049		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s048s049,021246s034s035lbl.pdf	3/3/2010
AP	2/22/2010	SE2	43422	049		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021087Orig1s049.pdf	7/20/2015
AP	11/5/2010	SLR	26915	055		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021087s055lbl.pdf	11/5/2010
AP	11/5/2010	SLR	26921	055		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021087s055,021246s038ltr.pdf	11/10/2010
AP	3/21/2011	SLR	28309	056		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s056_021246s039lbl.pdf	3/23/2011
AP	3/21/2011	SLR	28333	056		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s056,021246s039ltr.pdf	3/24/2011
AP	3/21/2011	SLR	36184	056		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021087Orig1s056.pdf	6/3/2013
AP	2/7/2011	SLR	27760	057		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021087s057lbl.pdf	2/7/2011
AP	2/7/2011	SLR	27793	057		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021087s057,021246s040ltr.pdf	2/9/2011
AP	8/16/2012	SLR	33506	059		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s059,021246s042lbl.pdf	8/17/2012
AP	8/16/2012	SLR	33513	059		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s059,021246Orig1s042ltr.pdf	8/20/2012
AP	11/26/2014	SLR	41119	060		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s060,021246Orig1s043ltr.pdf	11/28/2014
AP	11/26/2014	SLR	41134	060		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s060,021246s043lbl.pdf	12/3/2014
AP	1/29/2013	S	34995	061		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021087Orig1s061,021246Orig1s044ltr.pdf	1/29/2013
AP	1/29/2013	S	36772	061		http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044lbl.pdf	8/12/2013
AP	1/29/2013	S	36779	061	Package Labeling	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021087s061,021246s044pkglbl.pdf	8/12/2013
AP	12/21/2012	SE5	34733	062		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021087s062lbl.pdf	12/21/2012
AP	12/21/2012	SE5	34735	062		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021087Orig1s062,021246Orig1s045ltr.pdf	12/21/2012
AP	12/21/2012	SE5	34736	062		http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2012/021087Orig1s062021246Orig1s045SumR.pdf	12/21/2012
AP	12/21/2012	SE5	35638	062		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021246Orig1s045_021087Orig1s062_tamiflu_toc.cfm	4/8/2013
AP	12/20/2013	SCM
AP	5/30/2014	SLR	39425	064		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s064,021246Orig1s047ltr.pdf	6/3/2014
AP	5/30/2014	SLR	39436	064		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s064,021246s047lbl.pdf	6/3/2014
AP	10/14/2014	SLR	40778	065		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021087s065,021246s048lbl.pdf	10/15/2014
AP	10/14/2014	SLR	40792	065		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021087Orig1s065,021246Orig1s048ltr.pdf	10/16/2014
AP	10/8/2014	SCM
AP	12/15/2014	SCM
AP	6/20/2016	SLR	46389	068		http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf	6/21/2016
AP	6/20/2016	SLR	46397	068		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021087Orig1s068,021246Orig1s051ltr.pdf	6/22/2016

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