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FDA Drug Application 018281 by NOVARTIS

Application Number	018281
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
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	12/14/1981	N	34683	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246796.pdf	12/18/2012
AP	2/11/1982	SLR
AP	6/21/1983	SCP
AP	1/10/1986	SLR
AP	1/10/1986	SLR
AP	2/3/1986	SCP
AP	9/11/1986	SCM
AP	7/31/1987	SLR
AP	10/11/1995	SE5
AP	8/1/1988	SLR
AP	4/7/1989	SCP
AP	7/21/1989	SLR
AP	3/27/1990	SCM
AP	3/29/1990	SCM
AP	3/29/1990	SCM
AP	3/26/1990	SLR
AP	2/3/1995	SCS
AP	11/23/1992	SCF
AP	3/14/1991	SCS
AP	10/6/1993	SCS
AP	7/15/1998	SLR
AP	7/15/1998	SLR	17111	031	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/018927_S031_TEGRETOL_AP.PDF	7/6/2007
AP	7/15/1998	SLR
AP	4/10/2000	SLR
AP	7/15/1998	SLR
AP	1/27/1999	SCM
AP	4/23/1999	SCP
AP	4/10/2000	SLR
AP	4/11/2000	SCM
AP	3/7/2001	SLR	3911	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20234S17LTR.PDF	3/7/2001
AP	3/7/2001	SLR	3923	039	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF	3/7/2001
AP	3/7/2001	SLR	17110	039	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018281_S039_TEGRETOL_AP.PDF	7/6/2007
AP	5/18/2000	SCM
AP	11/15/2001	SCM
AP	1/28/2002	SCS
AP	3/5/2002	SCS
AP	8/16/2007	SLR	17640	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf	8/17/2007
AP	8/16/2007	SLR	17649	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf	8/17/2007
AP	8/28/2015	SLR	43774	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf	9/1/2015
AP	8/28/2015	SLR	43789	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf	9/3/2015
AP	12/11/2007	SLR	18644	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018281s046lbl.pdf	12/12/2007
AP	12/11/2007	SLR	18845	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s098, 018281s046, 018927s039, 020234s028_ltr.pdf	1/9/2008
AP	9/16/2014	SLR	40510	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf	9/17/2014
AP	9/16/2014	SLR	40525	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf	9/19/2014
AP	4/23/2009	SLR	22373	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf	5/1/2009
AP	4/23/2009	SLR	22519	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf	5/12/2009
AP	3/3/2011	SLR	28098	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf	3/7/2011
AP	3/3/2011	SLR	28139	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf	3/7/2011
AP	3/3/2011	SLR	28142	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf	3/7/2011
AP	3/3/2011	SLR	28099	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf	3/7/2011
AP	3/3/2011	SLR	28140	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033MedG.pdf	3/7/2011
AP	3/3/2011	SLR	28141	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf	3/7/2011
AP	1/16/2014	SLR	38322	051	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s103,018281Orig1s051,018927Orig1s044,020234Orig1s035ltr.pdf	1/17/2014
AP	1/16/2014	SLR	38327	051	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf	1/17/2014
AP	3/6/2013	SLR	35360	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016608sOrig1s105,018281Orig1s053,018927Orig1s046,020234Orig1s038ltr.pdf	3/8/2013
AP	3/6/2013	SLR	35385	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf	3/8/2013
AP	10/30/2011	SLR
AP	12/11/2012	SLR	34631	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf	12/13/2012
AP	12/11/2012	SLR	34652	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016608Orig1s107,018281Orig1s055,018927Orig1s048,020234Orig1s040ltr.pdf	12/13/2012
AP	11/8/2013	SCM

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