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FDA Drug Application 017512 by BAXTER HLTHCARE

Application Number	017512
Application Type	New Drug Application
Sponsor Applicant	BAXTER HLTHCARE
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	9/27/1978	N
AP	11/21/1978	SCF
AP	8/2/1979	SCS
AP	2/27/1979	SLR
AP	6/28/1980	SCS
AP	8/7/1980	SCS
AP	6/2/1980	SCS
AP	6/2/1980	SLR
AP	6/2/1980	SCP
AP	5/30/1980	SCS
AP	6/2/1980	SCS
AP	6/2/1980	SLR
AP	6/2/1980	SLR
AP	6/18/1980	SCS
AP	4/16/1981	SCS
AP	8/6/1980	SCS
AP	7/16/1985	SCS
AP	7/16/1985	SLR
AP	7/31/1980	SCS
AP	1/21/1981	SCS
AP	6/29/1981	SCS
AP	10/5/1981	SCF
AP	10/5/1981	SLR
AP	11/13/1981	SCS
AP	12/21/1981	SCS
AP	8/26/1981	SLR
AP	4/16/1982	SCS
AP	6/3/1982	SCS
AP	4/9/1982	SCS
AP	4/9/1982	SLR
AP	11/20/1981	SCS
AP	12/15/1981	SCS
AP	2/16/1982	SCS
AP	12/3/1982	SLR
AP	12/8/1982	SCS
AP	12/8/1982	SLR
AP	12/8/1982	SCS
AP	12/8/1982	SLR
AP	1/24/1985	SCS
AP	3/16/1984	SCS
AP	8/28/1985	SCS
AP	8/28/1985	SCS
AP	11/7/1983	SCS
AP	11/7/1983	SLR
AP	2/28/1984	SCS
AP	7/9/1984	SCP
AP	7/9/1984	SLR
AP	9/22/1984	SCS
AP	6/13/1985	SCS
AP	4/10/1985	SLR
AP	8/29/1985	SPD
AP	8/29/1985	SPD
AP	7/16/1985	SCS
AP	7/16/1985	SLR
AP	4/15/1985	SCS
AP	2/27/1986	SCP
AP	11/18/1985	SCP
AP	11/18/1985	SLR
AP	9/4/1986	SCP
AP	5/27/1986	SCM
AP	5/28/1987	SCS
AP	10/16/1989	SCS
AP	10/16/1989	SLR
AP	1/14/1987	SCS
AP	7/25/1987	SCP
AP	1/10/1989	SCF
AP	1/10/1989	SLR
AP	1/12/1989	SCS
AP	7/26/1989	SCS
AP	7/11/1990	SCF
AP	7/11/1990	SLR
AP	2/15/1991	SCS
AP	11/28/1990	SLR
AP	6/12/1992	SCM
AP	6/14/1993	SCM
AP	4/29/1991	SCS
AP	11/23/1992	SCS
AP	7/21/1995	SCP
AP	7/1/1994	SCS
AP	9/30/1994	SCS
AP	2/18/1994	SCS
AP	7/2/1996	SCP
AP	1/17/1997	SCP
AP	4/29/1997	SCP
AP	9/20/2000	SCP
AP	8/22/2001	SCS
AP	9/20/2002	SCP
AP	8/9/2005	SLR	12584	104	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf	8/11/2005
AP	8/9/2005	SLR	12583	106	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf	8/11/2005
AP	12/19/2008	SLR	21406	108	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017512s108ltr.pdf	12/24/2008
AP	12/19/2008	SLR	21449	108	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017512s108lbl.pdf	1/2/2009
AP	4/19/2013	SLR	35785	113	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf	4/23/2013
AP	4/19/2013	SLR	35835	113	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf	4/24/2013
AP	4/26/2013	SCM
AP	9/30/2014	SCM
AP	2/9/2015	SLR	41811	118	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf	2/10/2015
AP	2/9/2015	SLR	41816	118	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf	2/10/2015
AP	5/22/2015	SCM
AP	7/29/2015	SCM	43530	120	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf	7/30/2015
AP	7/29/2015	SCM	43553	120	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121ltr.pdf	7/31/2015
AP	7/29/2015	SCM	43531	121	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s120s121lbl.pdf	7/30/2015
AP	7/29/2015	SCM	43554	121	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s120,s121ltr.pdf	7/31/2015
AP	9/1/2015	SLR	43797	122	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf	9/4/2015
AP	9/1/2015	SLR	43814	122	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf	9/4/2015
AP	8/16/2016	SLR	46785	123	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf	8/17/2016
AP	8/16/2016	SLR	46801	123	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf	8/18/2016
AP	8/1/2016	SCM

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