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FDA Drug Application 008085 by DAVA PHARMS INC

Application Number	008085
Application Type	New Drug Application
Sponsor Applicant	DAVA PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/7/1953	N
AP	1/26/1976	S
AP	4/29/1977	SCP
AP	4/29/1977	SLM
AP	5/1/1979	SCS
AP	7/10/1978	SCS
AP	9/5/1979	SCF
AP	2/4/1983	SCF
AP	8/4/1983	SCS
AP	4/4/1984	SCS
AP	7/19/1984	SCS
AP	10/31/1988	SCP
AP	10/31/1988	SE1
AP	9/16/1986	SLR
AP	12/8/1986	SCM
AP	1/18/1990	SLR
AP	11/16/1989	SCM
AP	4/24/1989	SLR
AP	5/18/1989	SCS
AP	10/24/1990	SCS
AP	7/24/1991	SLR
AP	10/5/1990	SCS
AP	5/20/1997	SLR
AP	11/8/2000	SLR
AP	6/18/1998	SCM
AP	10/29/1999	SLR
AP	2/9/2000	SCP
AP	5/8/2001	SLR
AP	10/24/2003	SLR	6865	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf	11/5/2003
AP	10/24/2003	SLR	6881	052	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf	11/5/2003
AP	2/20/2002	SLR	4773	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf	2/20/2002
AP	2/20/2002	SLR	3653	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf	2/20/2002
AP	10/24/2003	SCM	6879	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08085slr052,scm055ltr.pdf	11/5/2003
AP	10/24/2003	SCM	6880	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08085slr052,scm055_rheumatrex_lbl.pdf	11/5/2003
AP	5/31/2006	SLR	14213	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/008085s058LTR.pdf	6/2/2006
AP	12/2/2015	SCM
AP	1/29/2016	SLR	45058	066	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/008085Orig1s066ltr.pdf	2/1/2016
AP	1/29/2016	SLR	45184	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf	2/18/2016

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