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FDA Drug Application 020692 by GLAXOSMITHKLINE

Application Number	020692
Application Type	New Drug Application
Sponsor Applicant	GLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	9/19/1997	N	13177	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm	11/30/2005
AP	9/19/1997	N	13224	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020692s000_SereventTOC.cfm	12/6/2005
AP	9/19/1997	N	24077	000	http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089125.pdf	11/20/2009
AP	9/25/1998	SE1	594	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf	9/25/1998
AP	9/25/1998	SE1	595	001	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm	9/25/1998
AP	9/25/1998	SE1	596	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf	9/25/1998
AP	9/25/1998	SE5	624	002	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf	9/25/1998
AP	9/25/1998	SE5	625	002	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm	9/25/1998
AP	9/25/1998	SE5	626	002	http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf	9/25/1998
AP	3/26/1998	SCS
AP	3/18/1998	SCS
AP	12/3/1998	SCS
AP	3/11/1998	SLR
AP	3/18/1998	SCS
AP	1/19/2001	SCS
AP	7/20/1999	SCM
AP	6/29/2000	SE8
AP	4/3/2000	SCS
AP	6/15/2000	SCS
AP	5/17/2001	SLR
AP	3/22/2002	SE1	3236	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20692s016ltr.pdf	3/22/2002
AP	3/22/2002	SE1	3237	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf	3/22/2002
AP	10/16/2001	SCS
AP	5/15/2002	SCM
AP	5/17/2002	SCS
AP	8/11/2003	SLR	6506	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.pdf	8/15/2003
AP	8/11/2003	SLR	6531	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20692slr024ltr.pdf	8/15/2003
AP	8/11/2003	SLR	20405	024	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020692_s024_SEREVENT DISKUS.pdf	8/1/2008
AP	9/28/2004	SLR	10346	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf	10/4/2004
AP	9/28/2004	SLR	10347	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf	10/4/2004
AP	2/23/2007	SLR	15917	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020692s028lbl.pdf	2/26/2007
AP	2/23/2007	SLR	15923	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf	3/1/2007
AP	3/2/2006	SLR	13706	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf	3/3/2006
AP	3/2/2006	SLR	13827	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf	3/23/2006
AP	3/20/2008	SLR	19499	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf	3/21/2008
AP	3/20/2008	SLR	19512	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf	3/24/2008
AP	12/30/2010	SLR	27435	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf	1/4/2011
AP	12/30/2010	SLR	27441	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s032ltr.pdf	1/4/2011
AP	11/18/2010	SLR	27005	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s035ltr.pdf	11/22/2010
AP	6/25/2010	SLR	25826	036	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf	6/28/2010
AP	6/25/2010	SLR	25851	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf	6/29/2010
AP	5/10/2011	SLR	28791	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf	5/12/2011
AP	5/10/2011	SLR	28818	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf	5/16/2011
AP	5/10/2011	SLR	28823	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf	5/16/2011
AP	6/27/2011	SLR	29386	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf	7/5/2011
AP	8/9/2012	SLR
AP	8/9/2012	SLR	33427	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf	8/13/2012
AP	4/14/2014	SLR	39044	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020692Orig1s043ltr.pdf	4/16/2014
AP	4/14/2014	SLR	39054	043	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf	4/16/2014
AP	6/17/2016	SCM
AP	9/30/2016	SLR	47278	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020692Orig1s045ltr.pdf	10/5/2016
AP	9/30/2016	SLR	47306	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020692s045lbl.pdf	10/6/2016

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