FDA Drug Application 019957 by FOUGERA PHARMS

Application Number	019957
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	12/14/1990	N
AP	8/17/1995	SLR
AP	10/7/1994	SCS
AP	6/7/1994	SCM
AP	10/7/1994	SCM
AP	6/7/1995	SCS
AP	11/12/1998	SCM
AP	12/9/2001	SLR	5901	007	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf	6/10/2003
AP	6/30/1999	SCM
AP	12/9/2001	SLR	5902	009	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf	6/10/2003
AP	6/7/2000	SCS
AP	1/18/2002	SE5	5005	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf	4/8/2003
AP	1/18/2002	SE5	8880	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf	6/2/2004
AP	2/18/2015	SLR	41872	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf	2/19/2015
AP	2/18/2015	SLR	41887	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf	2/20/2015

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