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FDA Drug Application 018657 by BAXTER HLTHCARE

Application Number	018657
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	12/24/1981	N
AP	6/30/1982	SLR
AP	12/20/1984	SLR
AP	8/8/1984	SCM
AP	8/21/1987	SLR
AP	11/13/1984	SCS
AP	2/17/1988	SLR
AP	2/17/1988	SE5
AP	4/24/1986	SCS
AP	2/17/1988	SLR
AP	8/26/1986	SLR
AP	12/28/1987	SLR
AP	4/13/1989	SLR
AP	7/2/1991	SCS
AP	9/25/1991	SCE
AP	11/8/1991	SCS
AP	4/2/1993	SCS
AP	5/15/1992	SCP
AP	8/9/1993	SCM
AP	9/21/1994	SCS
AP	2/28/1995	SCS
AP	4/16/1996	SCS
AP	5/13/1997	SCP
AP	1/30/1998	SCM
AP	6/2/2004	SLR	9106	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf	6/7/2004
AP	6/2/2004	SLR	9116	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf	6/7/2004
AP	6/2/2004	SLR	9107	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf	6/7/2004
AP	6/2/2004	SLR	9118	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf	6/7/2004
AP	5/25/2012	SLR	32778	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018657s028ltr.pdf	5/30/2012
AP	8/6/2009	SLR	23373	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf	9/17/2009
AP	8/6/2009	SLR	23962	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018657s029ltr.pdf	11/19/2009
AP	8/5/2011	SLR	29725	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018657s031ltr.pdf	8/9/2011
AP	8/5/2011	SLR	29770	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf	8/12/2011
AP	10/24/2013	SLR	37565	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018657Orig1s032ltr.pdf	10/25/2013
AP	10/24/2013	SLR	37581	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf	10/25/2013
AP	7/13/2015	SLR	43365	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018657Orig1s034ltr.pdf	7/14/2015
AP	7/13/2015	SLR	43384	034	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018657s034lbl.pdf	7/16/2015
AP	1/13/2016	SCM

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