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FDA Drug Application 013263 by ROCHE

Application Number	013263
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	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/15/1963	N
AP	12/13/1974	SCS
AP	1/24/1975	SCS
AP	6/18/1975	SCS
AP	8/25/1975	SCS
AP	8/27/1976	SLR
AP	10/27/1976	SLR
AP	12/14/1976	SLR
AP	9/21/1977	SLR
AP	3/30/1978	SLR
AP	2/26/1980	SCS
AP	4/4/1979	SCP
AP	11/2/1979	SLR
AP	9/20/1979	SCF
AP	1/9/1981	SCF
AP	5/19/1980	SLR
AP	6/17/1980	SCP
AP	10/14/1980	SCS
AP	7/17/1981	SCM
AP	3/26/1981	SLR
AP	3/4/1983	SCE
AP	5/11/1982	SCS
AP	8/11/1982	SCS
AP	10/18/1982	SCP
AP	10/18/1982	SCP
AP	10/18/1982	SCP
AP	10/18/1982	SLR
AP	11/30/1982	SCP
AP	12/10/1982	SCP
AP	1/20/1983	SCS
AP	1/20/1983	SCS
AP	1/13/1984	SLR
AP	1/13/1984	SCS
AP	4/16/1985	SCM
AP	8/27/1986	SCE
AP	1/20/1988	SCS
AP	2/7/2002	SLR	9607	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf	6/29/2004
AP	2/7/2002	SLR	17100	072	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S072_VALIUM_AP.pdf	7/6/2007
AP	11/8/1988	SCM
AP	10/26/1989	SCM
AP	2/7/2002	SLR	2090	075	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf	2/7/2002
AP	2/7/2002	SLR	17094	075	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf	7/6/2007
AP	9/5/1997	SCS
AP	11/5/1997	SCM
AP	9/19/1997	SCP
AP	9/4/1998	SCS
AP	5/12/2008	SLR	19823	080	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf	5/14/2008
AP	8/30/2000	SCM	17095	081	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf	7/6/2007
AP	5/9/2001	SCM	2098	082	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13263s82ltr.pdf	5/9/2001
AP	5/9/2001	SCM	15224	082	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013263_S082_Valium_APPROVAL PACKAGE.pdf	10/25/2006
AP	5/12/2008	SLR	19824	083	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf	5/14/2008
AP	5/12/2008	SLR	19940	083	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf	6/5/2008
AP	10/25/2001	SCM
AP	11/8/2001	SCP
AP	2/12/2002	SCS	2095	086	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13263s86ltr.pdf	2/12/2002
AP	2/12/2002	SCS	17139	086	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf	7/9/2007
AP	4/19/2013	SCM
AP	10/22/2013	SLR	37539	092	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/013263Orig1s092ltr.pdf	10/24/2013
AP	10/22/2013	SLR	37588	092	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf	10/25/2013
AP	7/30/2015	SCM

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