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FDA Drug Application 014399 by US PHARM HOLDINGS

Application Number	014399
Application Type	New Drug Application
Sponsor Applicant	US PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New ester, new salt, or other noncovalent derivative
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/20/1964	N	16529	000	http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273	5/9/2007
AP	7/2/1974	SCS
AP	4/4/1975	SCS
AP	6/25/1976	SES
AP	4/15/1975	SCS
AP	5/28/1976	SLR
AP	10/6/1975	SLR
AP	2/14/1980	SCF
AP	8/18/1980	SLR
AP	7/28/1980	SLR
AP	2/1/1982	SCF
AP	2/11/1982	SCF
AP	2/1/1982	SCP
AP	2/1/1982	SCS
AP	2/1/1982	SCS
AP	6/22/1982	SCS
AP	6/22/1982	SCM
AP	4/29/1985	SLR
AP	12/10/1990	SLR
AP	6/24/1986	SCS
AP	4/3/1987	SCS
AP	11/15/1988	SCP
AP	6/20/1988	SCP
AP	3/30/1988	SCM
AP	3/21/1989	SCM
AP	12/10/1990	SLR
AP	4/25/1990	SCS
AP	6/19/1989	SCM
AP	12/11/1991	SLR
AP	12/11/1991	SLR
AP	5/23/2000	SLR
AP	9/3/1992	SCM
AP	5/23/2000	SLR
AP	5/23/2000	SLR
AP	5/23/2000	SLR
AP	1/12/2005	SLR	10963	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14399s062ltr.pdf	1/13/2005
AP	1/12/2005	SLR	10964	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf	1/13/2005
AP	4/11/2006	SLR	13891	063	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf	4/12/2006
AP	4/11/2006	SLR	13911	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014399s063ltr.pdf	4/13/2006
AP	7/30/2007	SLR	17425	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf	7/31/2007
AP	7/30/2007	SLR	17436	064	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf	7/31/2007
AP	10/26/2009	SLR	23702	065	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf	10/30/2009
AP	10/26/2009	SLR	23703	065	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065MedGuide.pdf	10/30/2009
AP	10/26/2009	SLR	23959	065	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf	11/19/2009
AP	11/19/2012	SLR	34441	066	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf	11/21/2012
AP	11/19/2012	SLR	34459	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf	11/26/2012
AP	11/19/2012	SLR	34461	066	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf	11/26/2012
AP	11/19/2012	SLR	34442	067	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf	11/21/2012
AP	11/19/2012	SLR	34460	067	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf	11/26/2012
AP	11/19/2012	SLR	34462	067	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf	11/26/2012
AP	8/7/2014	SCM
AP	7/2/2014	SLR	39739	069	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf	7/3/2014
AP	7/2/2014	SLR	39740	069	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014399Orig1s069ltr.pdf	7/3/2014
AP	9/29/2016	SCM

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