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FDA Drug Application 050596 by US PHARM HOLDINGS

Application Number	050596
Application Type	New Drug Application
Sponsor Applicant	US PHARM HOLDINGS
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	5/20/1985	N
AP	6/13/1985	SLR
AP	9/23/1985	SLR
AP	7/23/1985	SLR
AP	3/5/1992	SCF
AP	8/7/1989	SCS
AP	8/10/1992	SCS
AP	9/24/1996	SLR
AP	5/19/1994	SCM
AP	11/22/1994	SLR
AP	6/16/1994	SCM
AP	9/14/1994	SLR
AP	9/2/1994	SLR
AP	4/30/1996	SLR
AP	12/23/1996	SLR
AP	4/24/1997	SLR
AP	1/18/2002	SLR	2468	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf	1/18/2002
AP	2/18/2000	SCM
AP	4/10/2001	SCS
AP	4/12/2001	SCM
AP	7/27/2001	SCM
AP	9/6/2001	SCS
AP	6/23/2004	SLR	9525	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf	6/24/2004
AP	9/2/2004	SLR
AP	2/21/2008	SLR	19283	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf	2/25/2008
AP	2/21/2008	SLR	19289	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf	2/25/2008
AP	5/27/2009	SLR	22670	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf	6/2/2009
AP	9/9/2011	SLR	29986	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf	9/13/2011
AP	9/9/2011	SLR	30024	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf	9/16/2011
AP	5/3/2013	SCM
AP	2/21/2014	SLR	38571	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf	2/25/2014
AP	2/21/2014	SLR	38582	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf	2/25/2014
AP	4/21/2014	SCM
AP	3/23/2015	SLR	42246	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf	3/24/2015
AP	3/23/2015	SLR	42527	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf	4/14/2015

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