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FDA Drug Application 020142 by NOVARTIS

Application Number	020142
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New ester, new salt, or other noncovalent derivative
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/24/1993	N	23892	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM135935.pdf	11/16/2009
AP	1/11/1995	SCS
AP	7/6/1994	SCM
AP	7/28/1995	SLR
AP	11/28/1995	SCM
AP	4/20/1998	SLR
AP	10/31/2001	SLR
AP	5/16/1997	SCM
AP	11/12/1997	SCS
AP	4/22/1999	SCP
AP	7/10/2000	SCM
AP	9/15/2000	SCM
AP	7/13/2001	SCM
AP	3/11/2002	SCM
AP	9/19/2002	SCS
AP	1/24/2006	SLR	13479	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020142s017lbl.pdf	1/25/2006
AP	1/24/2006	SLR	13538	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020254s016_020142s017_019201s035ltr.pdf	1/30/2006
AP	2/25/2009	SLR	21929	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020142s019ltr.pdf	3/3/2009
AP	2/25/2009	SLR	22016	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020142s019lbl.pdf	3/17/2009
AP	2/23/2011	SLR	27980	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28042	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf	3/4/2011
AP	2/23/2011	SLR	27981	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020142s021,s022ltr.pdf	2/28/2011
AP	2/23/2011	SLR	28043	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020142s021s022lbl.pdf	3/4/2011
AP	11/24/2014	SCM
AP	5/9/2016	SLR	45965	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020142s027lbl.pdf	5/11/2016
AP	5/9/2016	SLR	46004	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020142Orig1s027ltr.pdf	5/12/2016

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