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FDA Drug Application 006488 by FRESENIUS KABI USA

Application Number	006488
Application Type	New Drug Application
Sponsor Applicant	FRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type
Therapeutic Potential
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	11/19/1948	N
AP	12/4/1972	SLR
AP	5/20/1974	SCS
AP	6/24/1974	S
AP	8/28/1975	SLR
AP	8/28/1975	SCS
AP	7/16/1975	SCS
AP	10/9/1975	SLR
AP	2/2/1976	SCM
AP	5/17/1978	SLR
AP	3/26/1979	SCS
AP	4/9/1979	SCS
AP	4/9/1979	SLR
AP	2/27/1979	SCS	31533	019	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/006488Orig1s019.pdf	1/27/2012
AP	12/31/1980	SLR
AP	8/29/1979	SLR
AP	4/17/1980	SCS
AP	10/1/1981	SCS
AP	7/26/1982	SCS
AP	7/26/1982	SLR
AP	10/1/1981	SLR
AP	12/12/1984	SPD
AP	2/22/1986	SCS
AP	2/22/1986	SLR
AP	3/25/1982	SCS
AP	6/28/1982	SCM
AP	12/3/1984	SLR
AP	3/22/1985	SCS
AP	3/22/1985	SLR
AP	3/21/1991	SCS
AP	3/21/1991	SLR
AP	11/13/1986	SCS
AP	11/13/1986	SLR
AP	8/29/1986	SCS
AP	8/29/1986	SLR
AP	2/27/1986	SLR
AP	5/19/1986	SLR
AP	9/16/1987	SCM
AP	3/18/1987	SLR
AP	9/11/1987	SCS
AP	9/11/1987	SLR
AP	12/2/1988	SCP
AP	12/2/1988	SLR
AP	7/11/1989	SCP
AP	10/2/1990	SCS
AP	10/20/1993	SCE
AP	2/18/1993	SCM
AP	4/13/1993	SCS
AP	11/21/1994	SCM
AP	7/11/1995	SCS
AP	7/18/1995	SCE
AP	12/8/1997	SCP
AP	1/3/1996	SCM
AP	5/31/1996	SCM
AP	5/2/1996	SCS
AP	5/26/1999	SLR
AP	3/6/1998	SCM
AP	12/14/2000	SCS
AP	12/8/2000	SCS
AP	7/17/2002	SCS
AP	2/19/2010	SLR	24853	074	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf	2/25/2010
AP	2/19/2010	SLR	25066	074	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006488s074ltr.pdf	3/18/2010
AP	6/11/2013	SCM
AP	4/9/2013	SCM
AP	10/29/2013	SCM
AP	2/16/2013	SCM
AP	3/28/2013	SLR
AP	2/13/2013	SCM
AP	2/20/2013	SCM
AP	7/22/2013	SCM
AP	12/26/2013	SCM
AP	3/3/2015	SCM
AP	3/17/2016	SCM

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