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FDA Drug Application 017090 by MALLINCKRODT INC

Application Number	017090
Application Type	New Drug Application
Sponsor Applicant	MALLINCKRODT INC
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	3/11/1973	N	16541	000	http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273	5/9/2007
AP	3/11/1973	N	34201	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326090.pdf	10/29/2012
AP	5/22/1974	SOA
AP	5/22/1974	SOA
AP	5/22/1974	SOA
AP	5/22/1974	SOA
AP	5/22/1974	SOA
AP	5/28/1974	SCS
AP	5/28/1974	SCS
AP	5/28/1974	SCS
AP	5/28/1974	SCS
AP	5/28/1974	SCS
AP	5/28/1974	SCS
AP	6/3/1974	SCS
AP	12/3/1975	SCS
AP	6/7/1977	SCS
AP	1/2/1979	SLR
AP	12/28/1979	SCS
AP	12/28/1979	SCS
AP	6/7/1979	SCM
AP	6/7/1979	SCP
AP	1/30/1980	SCP
AP	4/16/1980	SCP
AP	4/16/1980	SCM
AP	2/4/1981	SLR
AP	7/18/1986	SCE
AP	5/4/1983	SCP
AP	11/5/1984	SCS
AP	3/26/1984	SLR
AP	10/29/1984	SCS
AP	4/26/1985	SLR
AP	5/5/1985	SCS
AP	11/27/1985	SLR
AP	5/20/1986	SCS
AP	8/12/1987	SE2
AP	4/7/1989	SCP
AP	8/8/1989	SCM
AP	10/25/1989	SCM
AP	10/25/1989	SCM
AP	4/5/1990	SCP
AP	8/2/1991	SCS
AP	12/8/1992	SLR
AP	2/19/1993	SCS
AP	3/27/2000	SLR
AP	3/27/2000	SLR
AP	3/27/2000	SLR
AP	7/31/1997	SCS
AP	4/15/1999	SCP
AP	4/26/2000	SCS
AP	6/21/2000	SCM
AP	1/3/2002	SLR
AP	6/20/2002	SCM
AP	3/26/2004	SLR	8124	069	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17090slr069ltr.pdf	3/28/2004
AP	1/12/2005	SLR	10966	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17090s070ltr.pdf	1/13/2005
AP	1/12/2005	SLR	10986	070	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf	1/13/2005
AP	7/13/2007	SLR	17284	074	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf	7/16/2007
AP	7/13/2007	SLR	17349	074	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf	7/24/2007
AP	10/26/2012	SLR	34181	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf	10/26/2012
AP	10/26/2012	SLR	34199	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf	10/29/2012
AP	7/10/2014	SLR	39840	077	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf	7/11/2014
AP	7/10/2014	SLR	39855	077	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf	7/11/2014
AP	7/28/2014	SLR	40032	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf	7/29/2014
AP	7/28/2014	SLR	40038	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf	7/29/2014

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