Drug History: ACCUTANE

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:	ACCUTANE
FDA Application No:	(NDA) 018662
Active Ingredient(s):	ISOTRETINOIN
Company:	HLR

Label History

View the label approved on October 10, 2007 for ACCUTANE, (NDA) 018662

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
10/3/2007	058	Labeling Revision	Letter Label
1/13/2006	057	Supplement	Review
8/12/2005	056	Labeling Revision	Letter Label Review
8/10/2005	055	Supplement	Review
8/24/2004	054	Labeling Revision	Letter Label Review
3/26/2004	053	Supplement	Review
8/27/2003	052	Labeling Revision	Letter Label Review
6/20/2002	051	Labeling Revision	Letter Label
8/27/2003	048	Labeling Revision	Letter Label Review
4/12/2002	047	Labeling Revision	Letter Patient Package Insert
2/15/2002	046	Labeling Revision	Letter Label
12/31/2001	045	Labeling Revision	Letter Label
10/30/2001	044	Labeling Revision	Letter Label
5/2/2002	043	Efficacy Supplement with Clinical Data to Support	Letter Label
1/11/2001	042	Control Supplement	Review
12/31/2001	041	Labeling Revision	Letter Label
5/1/2000	040	Labeling Revision	Letter
5/1/2000	039	Labeling Revision	Letter
5/1/2000	038	Labeling Revision	Letter Review
4/30/1999	037	Package Change
5/17/1995	034	Labeling Revision
1/13/1994	033	Labeling Revision
10/8/1991	032	Control Supplement
10/16/1990	031	Package Change
3/7/1991	030	Labeling Revision
4/16/1990	029	Labeling Revision
8/9/1989	028	Package Change
4/4/1989	027	Manufacturing Change or Addition
4/28/1989	026	Package Change
11/16/1988	025	Package Change
8/26/1988	024	Labeling Revision
1/7/1988	023	Expiration Date Change
10/19/1987	022	Labeling Revision
6/3/1987	021	Control Supplement
6/1/1987	020	Labeling Revision
2/26/1987	019	Package Change
6/6/1986	018	Labeling Revision
6/6/1986	017	Labeling Revision
7/5/1985	016	Labeling Revision
4/30/1985	015	Labeling Revision
6/6/1986	014	New Dosage Regimen
11/27/1984	013	Control Supplement
11/1/1984	011	Manufacturing Change or Addition
6/6/1986	010	Labeling Revision
5/31/1984	009	Package Change
2/28/1984	008	Labeling Revision
6/19/1985	007	Control Supplement
8/9/1983	004	Labeling Revision
6/6/1986	003	Labeling Revision
6/30/1983	002	Manufacturing Change or Addition
6/6/1986	001	Labeling Revision
5/7/1982	000	Approval	Other Important Information from FDA

Therapeutic Equivalents