Drug History: METHOTREXATE SODIUM

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	METHOTREXATE SODIUM
FDA Application No:	(NDA) 008085
Active Ingredient(s):	METHOTREXATE SODIUM
Company:	DAVA PHARMS INC

Label History

View the label approved on November 5, 2003 for METHOTREXATE SODIUM, (NDA) 008085

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
5/31/2006	058	Labeling Revision	Letter
10/24/2003	055	Manufacturing Change or Addition	Letter Label
2/20/2002	054	Labeling Revision	Letter
2/20/2002	053	Labeling Revision	Letter
10/24/2003	052	Labeling Revision	Letter Label
5/8/2001	051	Labeling Revision
2/9/2000	050	Package Change
10/29/1999	048	Labeling Revision
6/18/1998	047	Manufacturing Change or Addition
11/8/2000	046	Labeling Revision
5/20/1997	045	Labeling Revision
10/5/1990	040	Control Supplement
7/24/1991	039	Labeling Revision
10/24/1990	038	Control Supplement
5/18/1989	036	Control Supplement
4/24/1989	035	Labeling Revision
11/16/1989	034	Manufacturing Change or Addition
1/18/1990	032	Labeling Revision
12/8/1986	031	Manufacturing Change or Addition
9/16/1986	030	Labeling Revision
10/31/1988	028	New or Modified Indication
10/31/1988	027	Package Change
7/19/1984	024	Control Supplement
4/4/1984	023	Control Supplement
8/4/1983	021	Control Supplement
2/4/1983	019	Formulation Revision
9/5/1979	017	Formulation Revision
7/10/1978	016	Control Supplement
5/1/1979	015	Control Supplement
4/29/1977	014	Labeling (MarkIV)
4/29/1977	013	Package Change
1/26/1976	011	Supplement
12/7/1953	000	Approval

Therapeutic Equivalents