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FDA Drug Application 006035 by EDISON THERAPS LLC

Application Number	006035
Application Type	New Drug Application
Sponsor Applicant	EDISON THERAPS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type
Therapeutic Potential
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/19/1946	N
AP	5/20/1975	SCS
AP	5/20/1975	SCS
AP	1/16/1976	SCS
AP	5/3/1976	SCS
AP	6/9/1977	SCP
AP	1/16/1979	SCS
AP	1/23/1979	SES
AP	5/15/1979	SES
AP	7/22/1980	SES
AP	6/17/1981	SES
AP	9/28/1981	SCS
AP	6/17/1981	SCS
AP	6/15/1981	SCM
AP	10/22/1984	SCS
AP	8/30/1984	SCS
AP	9/30/1985	SPD
AP	6/18/1985	SCS
AP	5/14/1985	SCF
AP	1/7/1986	SLR
AP	7/6/1987	SCS
AP	5/6/1987	SLR
AP	3/2/1989	SCF
AP	10/20/1989	SCF
AP	10/20/1989	SCS
AP	10/20/1989	SCM
AP	10/20/1989	SCS
AP	9/6/1990	SCS
AP	5/28/1991	SLR
AP	3/22/1995	SLR
AP	7/18/1994	SCF
AP	4/25/1994	SLR
AP	3/11/1993	SCM
AP	7/7/1994	SCP
AP	9/22/1995	SCP
AP	9/22/1995	SCS
AP	10/17/1995	SCS
AP	2/22/1996	SLR
AP	2/21/1996	SCM
AP	5/27/1997	SLR
AP	7/15/1997	SCS
AP	4/22/1999	SCP
AP	12/9/1999	SCM
AP	4/14/2000	SCM
AP	5/22/2001	SCS
AP	4/3/2001	SCM
AP	1/28/2002	SCM
AP	2/5/2002	SCM
AP	2/5/2002	SCM
AP	2/18/2004	SLR	7783	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06035slr072ltr.pdf	3/2/2004
AP	10/1/2003	SLR	6737	073	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06035slr073ltr.pdf	10/9/2003
AP	4/26/2007	SLR	16350	075	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/006035s075lbl.pdf	5/1/2007
AP	4/26/2007	SLR	16383	075	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/006035s07LTRd.pdf	5/1/2007
AP	6/25/2012	N	33001	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf	6/25/2012
AP	6/25/2012	N	33031	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006035s078ltr.pdf	6/27/2012
AP	6/25/2012	N	34990	078	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/006035Orig1S078.pdf	1/28/2013
AP	5/21/2013	SCM

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