FDA Drug Application 017643 by FRESENIUS

Application Number	017643
Application Type	New Drug Application
Sponsor Applicant	FRESENIUS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	10/7/1975	N
AP	3/28/1977	SLR
AP	8/28/1978	SCS
AP	3/15/1978	SCS
AP	9/6/1978	SCS
AP	9/6/1978	SLR
AP	7/10/1978	SCS
AP	3/6/1978	SCS
AP	12/28/1977	SLR
AP	4/25/1979	SCS
AP	4/25/1979	SLR
AP	11/8/1978	SLR
AP	1/30/1979	SCS
AP	4/9/1979	SCS
AP	4/9/1979	SCS
AP	1/2/1980	SCS
AP	10/23/1979	SCS
AP	9/7/1979	SCS
AP	7/9/1979	SCS
AP	8/16/1979	SLR
AP	12/14/1979	SCE
AP	2/26/1980	SLR
AP	10/15/1979	SCS
AP	12/14/1979	SLR
AP	9/28/1979	SLR
AP	10/15/1979	SCS
AP	5/14/1980	SCM
AP	7/11/1980	SLR
AP	2/10/1984	SCS
AP	6/20/1981	SLR
AP	6/17/1981	SCS
AP	1/27/1982	SCS
AP	6/7/1983	SLR
AP	5/27/1983	SLR
AP	5/27/1983	SCS
AP	9/19/1988	SLR
AP	5/2/1984	SCS
AP	7/27/1984	SCS
AP	1/31/1985	SCS
AP	1/29/1985	SCS
AP	4/10/1989	SCM
AP	6/20/1990	SCM
AP	6/6/1990	SLR
AP	5/18/1994	SCS
AP	8/24/1993	SCS
AP	11/8/1991	SCP
AP	2/17/1995	SCS
AP	12/20/2000	SLR
AP	4/29/1997	SCS
AP	3/18/1999	SCM
AP	7/21/1999	SCS
AP	9/27/2000	SCS
AP	8/22/2001	SCM
AP	4/16/2004	SCS	8383	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17643scs070,18449scs037,19942scs010ltr.pdf	4/20/2004
AP	4/24/2007	SLR	16287	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017643s072,018449s039lbl.pdf	4/25/2007
AP	4/24/2007	SLR	16421	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018449s039,017643s072ltr.pdf	5/1/2007
AP	12/15/2014	SCM
AP	4/21/2016	SCM
AP	5/31/2016	SCM

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