Back to FDA Applications sponsored by FRESENIUS KABI USA

FDA Drug Application 017029 by FRESENIUS KABI USA

Application Number	017029
Application Type	New Drug Application
Sponsor Applicant	FRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	2/22/1972	N
AP	8/29/1975	SCS
AP	2/9/1976	SCS
AP	3/17/1976	SCS
AP	1/9/1976	SCF
AP	1/9/1976	SCS
AP	2/9/1976	SLR
AP	6/16/1976	SCM
AP	12/4/1977	SLR
AP	1/26/1977	SCF
AP	12/3/1976	SCF
AP	12/3/1976	SCS
AP	12/14/1977	SCS
AP	5/23/1978	SLR
AP	11/21/1978	SCS
AP	11/21/1978	SCS
AP	10/31/1979	SCM
AP	10/31/1979	SCS
AP	3/24/1981	SCM
AP	2/24/1981	SLR
AP	9/17/1982	SCS
AP	5/6/1982	SLR
AP	9/21/1982	SCM
AP	9/21/1982	SCM
AP	1/4/1983	SCE
AP	11/2/1983	SCE
AP	11/2/1983	SCF
AP	5/16/1985	SCF
AP	11/2/1983	SCF
AP	11/2/1983	SCF
AP	11/2/1983	SCF
AP	11/2/1983	SCF
AP	12/5/1985	SCP
AP	12/5/1985	SCP
AP	12/5/1985	SCP
AP	12/5/1985	SCP
AP	12/5/1985	SCP
AP	12/5/1985	SCP
AP	11/6/1984	SCP
AP	7/29/1985	SES
AP	9/22/1987	SCP
AP	9/22/1987	SCP
AP	4/7/1986	SLR
AP	4/28/1986	SCS
AP	6/26/1992	SLR
AP	12/1/1989	SCP
AP	2/16/1988	SCS
AP	9/22/1988	SLR
AP	6/8/1989	SCP
AP	8/6/1998	SCM
AP	8/6/1998	SCM
AP	8/25/1993	SLR
AP	7/26/1996	SCS
AP	10/27/1994	SCM
AP	5/17/1995	SCM
AP	8/6/1998	SCM
AP	6/24/1997	SCS
AP	11/4/1997	SCS
AP	3/8/2000	SCP
AP	12/13/1999	SCM
AP	3/22/2002	SLR	2211	099	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17029s099ltr.pdf	3/22/2002
AP	9/23/2008	SLR	20890	108	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017029s108ltr.pdf	9/26/2008
AP	9/23/2008	SLR	20940	108	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017029s108lbl.pdf	10/3/2008
AP	6/11/2010	SLR	25731	120	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017029s120,017651s048ltr.pdf	6/14/2010
AP	6/11/2010	SLR	25780	120	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017029s120,017651s048lbl.pdf	6/24/2010
AP	6/24/2011	SLR	29389	128	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s128,017651s052ltr.pdf	7/5/2011
AP	12/23/2015	SCM
AP	12/23/2011	SLR	31262	131	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017029s131017651s055lbl.pdf	12/23/2011
AP	12/23/2011	SLR	31292	131	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017029s131,017651s055ltr.pdf	12/29/2011
AP	3/9/2015	SCM
AP	3/21/2014	SLR	38983	135	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017029Orig1s135,017651Orig1s059.pdf	4/7/2014
AP	9/24/2013	SCM
AP	7/21/2015	SCM
AP	6/9/2016	SCM

Back to FDA Applications sponsored by FRESENIUS KABI USA