Drug History: DURAGESIC-25

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	DURAGESIC-25
FDA Application No:	(NDA) 019813
Active Ingredient(s):	FENTANYL
Company:	ALZA

Label History

View the label approved on February 8, 2005 for DURAGESIC25, (NDA) 019813

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
2/4/2005	039	New Dosage Regimen	Letter Label
5/20/2003	036	New or Modified Indication	Letter Label
4/9/2001	030	Labeling Revision	Letter
11/9/2000	029	Control Supplement
11/9/2000	028	Control Supplement
4/26/2000	027	Control Supplement
11/1/2000	026	Labeling Revision
11/1/2000	025	Labeling Revision
12/2/1999	024	Control Supplement
4/11/2001	023	Labeling Revision	Letter
12/7/1999	022	Package Change
7/17/1997	021	Labeling Revision	Review
7/17/1997	020	Labeling Revision	Review
7/17/1997	019	Labeling Revision	Review
7/17/1997	018	Labeling Revision	Review
11/7/1994	017	Labeling Revision
3/29/1994	016	Labeling Revision
6/19/1997	015	Control Supplement
1/11/1994	014	Labeling Revision
10/25/1993	012	Labeling Revision
6/11/1993	011	Formulation Revision
7/28/1993	010	Labeling Revision
6/12/1991	009	Manufacturing Change or Addition
7/5/1991	008	Manufacturing Change or Addition
2/12/1991	007	Control Supplement
10/22/1990	006	Manufacturing Change or Addition
10/22/1990	001	Manufacturing Change or Addition
8/7/1990	000	Approval	Other Important Information from FDA

Therapeutic Equivalents