Drug History: DERMA-SMOOTHE/FS

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:	DERMA-SMOOTHE/FS
FDA Application No:	(NDA) 019452
Active Ingredient(s):	FLUOCINOLONE ACETONIDE
Company:	HILL DERMAC

Label History

View the label approved on November 17, 2005 for DERMASMOOTHEFS, (NDA) 019452

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
11/9/2005	020	Efficacy Supplement with Clinical Data to Support	Letter Label
11/9/2005	019	Efficacy Supplement with Clinical Data to Support	Letter Label
4/21/2003	018	Package Change	Letter Label
10/10/2001	017	Patient Population Altered	Letter Label Review
11/9/2005	016	Efficacy Supplement with Clinical Data to Support	Letter Label
8/18/1999	015	New or Modified Indication	Letter Label Review
2/4/1997	014	Manufacturing Change or Addition
4/26/1996	013	Manufacturing Change or Addition
1/30/1996	012	Manufacturing Change or Addition
2/16/1995	010	New or Modified Indication
2/16/1995	009	Labeling Revision
6/25/1992	008	Package Change
8/27/1996	007	Control Supplement
10/16/1990	005	Manufacturing Change or Addition
1/10/1990	004	Manufacturing Change or Addition
6/27/1989	003	Manufacturing Change or Addition
3/15/1989	002	Manufacturing Change or Addition
9/8/1988	001	Manufacturing Change or Addition
2/3/1988	000	Approval

There are no Therapeutic Equivalents