Drug History: PLENDIL

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

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Label and Approval History

Drug Name:	PLENDIL
FDA Application No:	(NDA) 019834
Active Ingredient(s):	FELODIPINE
Company:	ASTRAZENECA

Label History

View the label approved on June 10, 2004 for PLENDIL, (NDA) 019834

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
6/7/2004	022	Labeling Revision	Letter Label
8/26/2002	020	Manufacturing Change or Addition
9/26/2002	019	Control Supplement
5/22/2002	017	Labeling Revision	Letter Label
11/23/1999	016	Manufacturing Change or Addition
8/28/2000	015	Labeling Revision
2/8/2000	014	Labeling Revision
7/14/1998	013	Labeling Revision
8/7/1997	012	Manufacturing Change or Addition
10/23/1997	010	Package Change
1/13/1998	009	Labeling Revision	Letter Label Review
12/12/1996	008	Control Supplement
7/29/1996	007	Control Supplement
7/3/1996	006	Control Supplement
2/5/1996	005	Package Change
7/14/1995	004	Labeling Revision
9/22/1994	002	New Dosage Regimen	Review
9/22/1993	001	Labeling Revision
7/25/1991	000	Approval

Therapeutic Equivalents