Drug History: PROSCAR

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:	PROSCAR
FDA Application No:	(NDA) 020180
Active Ingredient(s):	FINASTERIDE
Company:	MERCK

Label History

View the label approved on May 4, 2004 for PROSCAR, (NDA) 020180

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
4/23/2004	029	Labeling Revision	Letter Label Review
9/9/2003	027	Labeling Revision	Letter Label Review
4/12/2004	026	Efficacy Supplement with Clinical Data to Support	Letter Label Review
6/26/2003	025	Labeling Revision	Letter Review
11/26/2002	024	Control Supplement	Review
10/28/2002	023	Control Supplement	Review
1/30/2001	022	Labeling Revision
9/23/2003	020	Labeling Revision	Letter Review
1/17/2001	019	Labeling Revision
8/2/1999	018	Labeling Revision
12/19/1997	017	Labeling Revision	Review
3/20/1998	016	New or Modified Indication	Review
3/20/1998	015	Patient Population Altered	Review
5/16/1997	014	Control Supplement	Review
5/12/1997	013	Manufacturing Change or Addition	Review
8/28/1996	011	Labeling Revision	Review
7/24/1996	010	Manufacturing Change or Addition	Review
12/30/1994	009	Labeling Revision
5/18/1994	008	Labeling Revision
5/18/1994	007	Labeling Revision
9/16/1993	006	Package Change
9/1/1993	005	Manufacturing Change or Addition
4/5/1993	004	Package Change
12/22/1992	003	Labeling Revision
12/22/1992	002	Manufacturing Change or Addition
8/20/1992	001	Labeling Revision
6/19/1992	000	Approval

Therapeutic Equivalents