FDA Drug Application 017058 by ROXANE

Application Number	017058
Application Type	New Drug Application
Sponsor Applicant	ROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/14/1973	N
AP	5/4/1976	SLR
AP	3/25/1977	SLR
AP	3/25/1980	SCS
AP	4/25/1985	SCM
AP	1/28/1986	SLR
AP	10/10/1986	SCS
AP	10/31/1986	SCM
AP	9/28/1995	SCS
AP	9/22/1998	SCM
AP	3/30/1999	SCP
AP	9/18/2000	SCS
AP	12/7/2006	SLR	15461	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017058s017lbl.pdf	12/14/2006
AP	12/7/2006	SLR	15566	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017058s017ltr.pdf	12/28/2006
AP	2/4/2008	SLR	19073	019	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017058s019ltr.pdf	2/7/2008
AP	2/4/2008	SLR	19129	019	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017058s019lbl.pdf	2/14/2008
AP	8/24/2015	SCM
AP	9/19/2013	SLR	37183	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017058Orig1s021ltr.pdf	9/20/2013
AP	9/19/2013	SLR	37199	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017058s021lbl.pdf	9/24/2013

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