FDA Drug Application 016273 by US PHARM HOLDINGS

Application Number	016273
Application Type	New Drug Application
Sponsor Applicant	US PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	7/1/1966	N
AP	3/20/1975	SOA
AP	7/21/1976	SLR
AP	1/10/1977	SCE
AP	2/9/1977	SCP
AP	4/24/1978	SLR
AP	4/24/1978	SCS
AP	4/24/1978	SLR
AP	4/24/1978	SLR
AP	2/5/1980	SCP
AP	7/2/1979	SLR
AP	3/27/1981	SLR
AP	2/4/1981	SCM
AP	6/2/1986	SPD
AP	8/2/1982	SCP
AP	3/15/1983	SCP
AP	8/2/1983	SCM
AP	9/14/1983	SCE
AP	2/9/1987	SCM
AP	3/8/1991	SCS
AP	3/15/1990	SPD
AP	10/23/1991	SLR
AP	6/1/1992	SCP
AP	4/6/1992	SCP
AP	11/13/1992	SLR
AP	1/26/1995	SLR
AP	5/1/1995	SCM
AP	6/24/1996	SCM
AP	12/4/1997	SCM
AP	10/8/1998	SCP
AP	1/14/1999	SCP
AP	2/8/2006	SLR	13659	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016273s057ltr.pdf	2/22/2006
AP	10/22/2008	SLR	21050	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016273s060ltr.pdf	10/23/2008
AP	10/18/2010	SLR	26690	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf	10/18/2010
AP	10/18/2010	SLR	26716	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016273s061ltr.pdf	10/20/2010
AP	3/27/2012	SLR	32244	066	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016273s066ltr.pdf	3/28/2012
AP	3/27/2012	SLR	32268	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf	3/28/2012
AP	3/4/2016	SLR	45392	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016273Orig1s068ltr.pdf	3/8/2016
AP	3/4/2016	SLR	45393	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf	3/8/2016

Back to FDA Applications sponsored by US PHARM HOLDINGS