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FDA Drug Application 018240 by ALVOGEN MALTA

Application Number	018240
Application Type	New Drug Application
Sponsor Applicant	ALVOGEN MALTA
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	8/19/1981	N
AP	9/23/1981	SLR
AP	9/4/1985	SE1
AP	4/7/1983	SCF
AP	9/27/1983	SCP
AP	9/13/1989	SE1
AP	12/15/1983	SCS
AP	7/12/1984	SCM
AP	11/19/1984	SCS
AP	9/18/1985	SLR
AP	2/13/1987	SCP
AP	4/9/1990	SE2
AP	2/21/1991	SLR
AP	2/21/1991	SLR
AP	2/21/1991	SLR
AP	9/18/1991	SLR
AP	8/5/1992	SLR
AP	8/5/1992	SLR
AP	4/29/1993	SLR
AP	5/4/1994	SLR
AP	2/9/1996	SLR
AP	10/11/1996	SCP
AP	4/4/2000	SLR	3834	025	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf	6/4/2001
AP	7/21/1999	SLR	3831	026	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf	6/4/2001
AP	1/9/2003	SLR	3929	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr027ltr.pdf	1/9/2003
AP	11/6/2003	SLR	6902	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf	11/13/2003
AP	2/9/2005	SLR	11102	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18240s029ltr.pdf	2/11/2005
AP	4/29/2008	SLR	19758	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018240s030ltr.pdf	5/5/2008
AP	8/17/2011	SLR	29822	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018240s031ltr.pdf	8/18/2011
AP	8/17/2011	SLR	29870	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf	8/24/2011
AP	10/31/2012	SLR	34238	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018240Orig1s032ltr.pdf	11/5/2012
AP	10/31/2012	SLR	34292	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf	11/6/2012
AP	7/9/2015	SCM
AP	7/15/2015	SCM
AP	7/16/2015	SCM
AP	8/27/2015	SCM
AP	9/3/2015	SCM
AP	9/10/2015	SCM

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