Drug History: FLAGYL

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	FLAGYL
FDA Application No:	(NDA) 012623
Active Ingredient(s):	METRONIDAZOLE
Company:	GD SEARLE LLC

Label History

View the label approved on April 5, 2004 for FLAGYL, (NDA) 012623

To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.

Approval History

Action Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
3/17/2004	059	Labeling Revision	Letter Label
4/23/2003	058	Labeling Revision	Letter Label
2/16/1994	056	Package Change
6/23/1992	054	Package Change
5/7/1996	053	Labeling Revision
7/30/1990	052	Package Change
5/7/1996	051	Labeling Revision
4/13/1989	050	Labeling Revision
5/7/1996	049	Labeling Revision
5/7/1996	048	Labeling Revision
2/3/1989	047	Labeling Revision
6/18/1987	046	Expiration Date Change
12/28/1987	045	Labeling Revision
7/22/1986	044	Labeling Revision
2/10/1988	041	Patient Population Altered
11/3/1987	040	Labeling Revision
8/21/1987	038	Labeling Revision
3/30/1984	037	Labeling Revision
6/2/1983	036	Control Supplement
10/18/1983	035	Labeling Revision
10/18/1983	034	Practioner Draft Labeling
5/5/1982	033	Formulation Revision
8/13/1981	032	Package Change
2/4/1982	031	Manufacturing Change or Addition
8/4/1981	030	Manufacturing Change or Addition
12/12/1980	029	Package Change
1/9/1980	028	Formulation Revision
12/8/1980	027	Labeling Revision
2/27/1980	026	Formulation Revision
1/2/1980	025	Manufacturing Change or Addition
7/26/1979	024	Labeling Revision
3/2/1979	023	Labeling Revision
4/19/1979	022	Formulation Revision
8/22/1977	019	Labeling Revision
10/5/1976	018	Control Supplement
11/5/1975	015	Labeling Revision
5/14/1974	013	Labeling Revision
5/14/1974	012	Supplement
7/18/1963	000	Approval

Therapeutic Equivalents