FDA Drug Application 018702 by FOUGERA PHARMS

Application Number	018702
Application Type	New Drug Application
Sponsor Applicant	FOUGERA PHARMS
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	12/14/1982	N
AP	11/7/1983	SLR
AP	5/20/1986	SCS
AP	1/16/1991	SCM
AP	6/7/1994	SCM
AP	4/26/1996	SLR
AP	6/22/1994	SCS
AP	4/2/2003	SLR	8806	007	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf	5/28/2004
AP	4/2/2003	SLR	8807	007	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf	5/28/2004
AP	7/26/2002	SCM	8578	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf	5/25/2004
AP	7/26/2002	SCM	8579	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf	5/25/2004
AP	4/5/2011	SLR	28473	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf	4/6/2011
AP	4/5/2011	SLR	28490	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf	4/11/2011

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