FDA Drug Application 050686 by PERNIX THERAP

Application Number	050686
Application Type	New Drug Application
Sponsor Applicant	PERNIX THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/20/1995	N
AP	10/9/1996	SLR
AP	5/21/1997	SLR
AP	9/10/1996	SCS
AP	9/3/1997	SCM
AP	3/3/1998	SCP
AP	2/16/1999	SLR
AP	6/15/1998	SLR
AP	10/2/1998	SCS
AP	5/19/2000	SLR
AP	1/4/2001	SCP
AP	2/10/2009	SLR	21807	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050685s011,050686s014ltr.pdf	2/12/2009
AP	2/10/2009	SLR	21819	014	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050685s011,050686s014lbl.pdf	2/12/2009
AP	11/4/2010	SLR	26907	015	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050685s012,050686s015ltr.pdf	11/8/2010
AP	3/11/2011	SCM	28242	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050686s016lbl.pdf	3/14/2011
AP	3/11/2011	SCM	28261	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050686s016ltr.pdf	3/16/2011

Back to FDA Applications sponsored by PERNIX THERAP