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FDA Drug Application 017105 by RECORDATI RARE

Application Number	017105
Application Type	New Drug Application
Sponsor Applicant	RECORDATI RARE
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	6/23/1972	N
AP	3/31/1975	SCS
AP	11/13/1975	SCS
AP	11/5/1975	SLR
AP	9/10/1975	SCS
AP	8/4/1976	SCS
AP	8/4/1976	SLR
AP	7/30/1976	SCS
AP	3/18/1977	SCS
AP	5/7/1976	SCF
AP	3/10/1980	SCM
AP	12/21/1976	SCM
AP	1/4/1977	SCM
AP	12/21/1976	SCM
AP	10/20/1977	SCF
AP	7/9/1979	SCS
AP	10/21/1977	SLR
AP	5/5/1978	SCF
AP	4/17/1978	SCF
AP	12/6/1978	SCP
AP	6/7/1979	SCS
AP	6/7/1979	SCS
AP	6/7/1979	SCM
AP	6/5/1979	SCF
AP	5/31/1979	SCS
AP	1/29/1981	SES
AP	12/12/1979	SLR
AP	7/14/1980	SLR
AP	9/8/1980	SCF
AP	10/28/1980	SCS
AP	2/27/1984	SCS
AP	6/16/1986	SCS
AP	8/26/1985	SCS
AP	8/29/1986	SCS
AP	11/14/1986	SCS
AP	1/8/1987	SCS
AP	8/13/1987	SCS
AP	2/7/2002	SLR	4021	059	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf	2/7/2002
AP	2/7/2002	SLR	17136	059	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S059_TRANXENE_AP.pdf	7/9/2007
AP	11/5/1987	SCP
AP	2/7/2002	SLR	4022	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17105s59s62ltr.pdf	2/7/2002
AP	2/7/2002	SLR	17135	062	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S062_TRANXENE_AP.pdf	7/9/2007
AP	11/8/1988	SCS
AP	11/5/1996	SCS
AP	8/4/1999	SCS
AP	5/8/1998	SCP
AP	8/28/2002	SCS
AP	3/13/2003	SLR	4508	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17105slr070ltr.pdf	3/26/2003
AP	3/13/2003	SLR	15226	070	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017105_S070_Tranxene_APPROVAL_PACKAGE.pdf	10/25/2006
AP	4/23/2009	SLR	22344	075	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017105s075lbl.pdf	4/28/2009
AP	4/23/2009	SLR	22356	075	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017105s075ltr.pdf	4/29/2009
AP	6/7/2010	SLR	25728	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076lbl.pdf	6/14/2010
AP	6/7/2010	SLR	25733	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017105s076ltr.pdf	6/15/2010
AP	6/7/2010	SLR	25775	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017105s076MedGuide.pdf	6/24/2010
AP	7/19/2011	SLR	29567	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017105s077ltr.pdf	7/21/2011
AP	2/3/2015	SCM

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