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FDA Drug Application 011719 by HOSPIRA

Application Number	011719
Application Type	New Drug Application
Sponsor Applicant	HOSPIRA
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	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	8/10/1959	N
AP	7/22/1975	SCS
AP	11/3/1975	SFP
AP	11/3/1975	SLR
AP	12/5/1975	SLR
AP	6/29/1976	SCM
AP	6/29/1976	SLR
AP	8/3/1976	SCM
AP	6/29/1976	SCS
AP	9/7/1976	SCS
AP	9/7/1976	SCM
AP	9/7/1976	SCS
AP	9/14/1976	SCS
AP	9/14/1976	SCS
AP	8/2/1977	SCM
AP	3/28/1977	SCM
AP	3/18/1977	SCS
AP	7/14/1977	SCM
AP	8/22/1978	SCS
AP	1/2/1979	SCS
AP	8/8/1978	SCM
AP	12/14/1978	SCS
AP	2/15/1979	SCS
AP	6/11/1980	SCM
AP	10/15/1979	SCM
AP	2/29/1980	SCS
AP	12/3/1980	SCE
AP	5/11/1981	SCM
AP	12/7/1981	SCM
AP	3/31/1982	SLR
AP	3/31/1982	SCS
AP	4/8/1983	SCM
AP	8/24/1982	SLR
AP	4/8/1983	SCS
AP	3/19/1987	SCM
AP	9/16/1986	SCM
AP	9/16/1986	SLR
AP	8/18/1987	SCM
AP	12/8/1986	SCM
AP	1/18/1990	SLR
AP	4/7/1988	SE1
AP	4/7/1988	SCS
AP	4/21/1988	SCF
AP	3/1/1989	SCS
AP	2/20/1991	SCS
AP	10/24/1990	SCS
AP	11/5/1991	SCP
AP	1/23/1992	SCM
AP	4/25/1995	SCS
AP	5/20/1997	SLR
AP	11/8/2000	SLR
AP	6/22/1998	SCM
AP	2/12/1999	SCS
AP	10/29/1999	SLR
AP	5/8/2001	SLR
AP	2/20/2002	SLR	4774	102	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf	2/20/2002
AP	2/20/2002	SLR	3566	103	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/08085s53s54ltr.pdf	2/20/2002
AP	1/3/2003	SLR	3564	104	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr104ltr.pdf	1/3/2003
AP	7/30/2003	SLR	6416	105	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11719slr105ltr.pdf	8/6/2003
AP	1/27/2004	SLR	7650	106	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719slr106ltr.pdf	2/2/2004
AP	1/27/2004	SLR	7654	106	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11719slr106_methotrexate_lbl.pdf	2/3/2004
AP	12/15/2004	SCM	10869	107	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11719s107ltr.pdf	12/30/2004
AP	4/13/2005	SCM	11435	108	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/011719s108ltr.pdf	4/19/2005
AP	11/1/2011	SLR	30480	117	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011719s117ltr.pdf	11/3/2011
AP	11/1/2011	SLR	30500	117	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011719s117lbl.pdf	11/4/2011
AP	8/14/2015	SCM
AP	11/20/2015	SLR	44564	122	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011719Orig1s122ltr.pdf	11/23/2015
AP	11/20/2015	SLR	44590	122	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011719s122lbl.pdf	11/25/2015
AP	2/3/2016	SCM

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