Drug History: FLUOROURACIL

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	FLUOROURACIL
FDA Application No:	(NDA) 012209
Active Ingredient(s):	FLUOROURACIL
Company:	VALEANT

Label History

View the label approved on April 7, 2003 for FLUOROURACIL, (NDA) 012209

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
7/31/2000	039	Control Supplement
1/20/1999	038	Package Change	Review
9/15/1997	036	Control Supplement
5/5/1995	035	Expiration Date Change
5/12/1994	033	Labeling Revision
10/18/1991	032	Control Supplement
5/20/1991	031	Labeling Revision
3/20/1989	030	Manufacturing Change or Addition
10/3/1988	029	Labeling Revision
5/19/1988	028	Control Supplement
10/21/1986	027	Manufacturing Change or Addition
11/26/1986	026	Labeling Revision
6/26/1985	025	Manufacturing Change or Addition
7/1/1986	023	Labeling Revision
7/19/1984	021	Labeling Revision
11/26/1986	020	Practioner Draft Labeling
5/12/1983	019	Labeling Revision
3/24/1982	018	Labeling Revision
4/4/1980	017	Manufacturing Change or Addition
11/8/1979	016	Control Supplement
1/10/1983	015	Control Supplement
9/29/1978	014	Labeling Revision
5/3/1977	013	Labeling Revision
9/29/1976	012	Control Supplement
9/27/1976	011	Package Change
9/27/1976	010	Control Supplement
7/22/1975	009	Control Supplement
4/25/1962	000	Approval	Label

Therapeutic Equivalents