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FDA Drug Application 018063 by US WORLDMEDS LLC

Application Number	018063
Application Type	New Drug Application
Sponsor Applicant	US WORLDMEDS LLC
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	12/10/1979	N
AP	2/11/1980	SLR
AP	2/11/1980	SLR
AP	8/14/1980	SCM
AP	1/27/1981	SCF
AP	10/22/1980	SCS
AP	12/30/1980	SLR
AP	3/17/1981	SCS
AP	1/27/1981	SCP
AP	8/28/1981	SCP
AP	4/2/1981	SCS
AP	7/9/1981	SCF
AP	7/24/1981	SCF
AP	8/28/1981	SCS
AP	10/15/1981	SCE
AP	3/2/1982	SCS
AP	4/1/1982	SCS
AP	6/2/1982	SCS
AP	10/1/1982	SCS
AP	9/22/1982	SCM
AP	11/18/1982	SCP
AP	3/29/1983	SCM
AP	3/29/1983	SCS
AP	7/21/1983	SCS
AP	10/14/1983	SCS
AP	11/1/1983	SCE
AP	11/16/1984	SES
AP	1/17/1984	SCS
AP	2/8/1984	SCP
AP	3/6/1984	SCP
AP	5/16/1984	SCE
AP	10/28/1986	SE2
AP	5/15/1984	SCS
AP	5/16/1984	SCS
AP	8/6/1984	SCS
AP	10/24/1984	SCP
AP	5/15/1985	SLR
AP	10/7/1986	SCS
AP	8/19/1986	SCS
AP	3/11/1987	SCE
AP	1/6/1987	SCP
AP	8/21/1990	SCS
AP	9/3/1987	SCP
AP	11/7/1990	SLR
AP	3/29/1991	SCM
AP	5/3/1991	SCS
AP	11/8/1991	SCM
AP	5/20/1992	SCM
AP	5/1/1992	SCF
AP	4/5/1994	SCS
AP	8/16/1995	SCM
AP	3/18/1996	SCS
AP	9/19/2001	SCM
AP	2/4/2008	SLR	19071	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018063s060ltr.pdf	2/7/2008
AP	2/4/2008	SLR	19131	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf	2/14/2008
AP	6/6/2011	SLR	29053	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018063s062ltr.pdf	6/7/2011
AP	6/6/2011	SLR	29281	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf	6/27/2011
AP	7/15/2013	SLR	36562	063	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf	7/15/2013
AP	7/15/2013	SLR	36563	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018063Orig1s063ltr.pdf	7/16/2013

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