FDA Drug Application 016042 by GLAXOSMITHKLINE LLC

Application Number	016042
Application Type	New Drug Application
Sponsor Applicant	GLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New combination
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/2/1965	N
AP	6/23/1976	SOA
AP	1/27/1976	SOA
AP	2/27/1975	SCP
AP	2/27/1975	SLR
AP	6/23/1976	SLR
AP	6/12/1975	SLR
AP	1/27/1976	SCF
AP	5/21/1976	SLR
AP	5/21/1976	SLR
AP	11/3/1976	SLR
AP	4/12/1977	SLR
AP	2/14/1977	SCP
AP	2/14/1977	SCP
AP	6/14/1977	SCF
AP	2/22/1978	SLR
AP	2/22/1978	SLR
AP	2/22/1978	SLR
AP	2/22/1978	SLR
AP	1/19/1978	SCM
AP	1/19/1978	SCP
AP	1/19/1978	SCS
AP	9/18/1979	SLR
AP	9/18/1979	SLR
AP	9/18/1979	SLR
AP	2/2/1981	SCF
AP	12/6/1979	SLR
AP	1/14/1980	SLR
AP	1/27/1981	SLR
AP	7/14/1980	SLR
AP	2/23/1982	SLR
AP	4/26/1988	SPD
AP	10/30/1981	SLR
AP	8/25/1982	SLR
AP	10/8/1982	SLR
AP	1/3/1985	SLR
AP	5/13/1983	SCM
AP	3/3/1994	SE1
AP	3/7/1985	SLR
AP	7/29/1986	SLR
AP	2/23/1988	SCS
AP	12/2/1991	SCF
AP	5/1/1992	SCS
AP	3/3/1994	SLR
AP	5/20/1994	SCS
AP	12/1/1994	SLR
AP	8/31/1998	SCM
AP	3/16/1999	SCM
AP	2/23/2001	SLR
AP	12/20/2000	SCM
AP	5/18/2007	SLR	16609	074	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016042s074ltr.pdf	5/29/2007
AP	2/23/2010	SLR	24861	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016042s077ltr.pdf	2/26/2010
AP	2/23/2010	SLR	24928	077	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016042s077lbl.pdf	3/3/2010
AP	3/15/2011	SLR	28267	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016042s078ltr.pdf	3/17/2011
AP	3/15/2011	SLR	28291	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016042s078lbl.pdf	3/21/2011

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