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Label and Approval History
Drug Name(s) ACCUTANE (Brand Name Drug)
FDA Application No. (NDA) 018662
Active Ingredient(s) ISOTRETINOIN
Company HOFFMANN LA ROCHE
Go to Approval History
Label Information

What information does a label include?
Note: Not all labels are available in electronic format from FDA.

    View the label approved on 11/19/2008  PDF file: requires free Adobe Acrobat Reader for ACCUTANE, NDA no. 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
NDA 018662

Note: Not all reviews are available in electronic format from FDA.
Older labels are for historical information only, and should not be used for clinical purposes.
Approval dates can only be verified from 1984 to the present.

Click on a column header to re-sort the table:

Action
Date
Supplement
Number
Approval
Type 		Letters,
Reviews,
Labels,
Patient Package Insert  		 Note
11/19/2008 059 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
10/03/2007 058 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
01/13/2006 057 SupplementReview  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
08/12/2005 056 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
08/10/2005 055 SupplementReview  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
08/24/2004 054 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
03/26/2004 053 SupplementReview  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
08/27/2003 048 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
08/27/2003 052 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		 
06/20/2002 051 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
05/02/2002 043 Efficacy Supplement with Clinical Data to SupportLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
04/12/2002 047 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader
Patient Package Insert  PDF file: requires free Adobe Acrobat Reader 		Label is not available
on this site. 
02/15/2002 046 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
12/31/2001 041 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
12/31/2001 045 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
10/30/2001 044 Labeling RevisionLabel  PDF file: requires free Adobe Acrobat Reader
Letter  PDF file: requires free Adobe Acrobat Reader 		 
01/11/2001 042 Control SupplementReview  PDF file: requires free Adobe Acrobat Reader This supplement type does
not usually require new labeling. 
05/01/2000 038 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader
Review  PDF file: requires free Adobe Acrobat Reader 		Label is not available
on this site. 
05/01/2000 039 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
05/01/2000 040 Labeling RevisionLetter  PDF file: requires free Adobe Acrobat Reader Label is not available
on this site. 
04/30/1999 037 Package Change Label is not available
on this site. 
05/17/1995 034 Labeling Revision Label is not available
on this site. 
01/13/1994 033 Labeling Revision Label is not available
on this site. 
10/08/1991 032 Control Supplement This supplement type does
not usually require new labeling. 
03/07/1991 030 Labeling Revision Label is not available
on this site. 
10/16/1990 031 Package Change Label is not available
on this site. 
04/16/1990 029 Labeling Revision Label is not available
on this site. 
08/09/1989 028 Package Change Label is not available
on this site. 
04/28/1989 026 Package Change Label is not available
on this site. 
04/04/1989 027 Manufacturing Change or Addition This supplement type does
not usually require new labeling. 
11/16/1988 025 Package Change Label is not available
on this site. 
08/26/1988 024 Labeling Revision Label is not available
on this site. 
01/07/1988 023 Expiration Date Change Label is not available
on this site. 
10/19/1987 022 Labeling Revision Label is not available
on this site. 
06/03/1987 021 Control Supplement This supplement type does
not usually require new labeling. 
06/01/1987 020 Labeling Revision Label is not available
on this site. 
02/26/1987 019 Package Change Label is not available
on this site. 
06/06/1986 001 Labeling Revision Label is not available
on this site. 
06/06/1986 003 Labeling Revision Label is not available
on this site. 
06/06/1986 010 Labeling Revision Label is not available
on this site. 
06/06/1986 014 New Dosage Regimen Label is not available
on this site. 
06/06/1986 017 Labeling Revision Label is not available
on this site. 
06/06/1986 018 Labeling Revision Label is not available
on this site. 
07/05/1985 016 Labeling Revision Label is not available
on this site. 
06/19/1985 007 Control Supplement This supplement type does
not usually require new labeling. 
04/30/1985 015 Labeling Revision Label is not available
on this site. 
11/27/1984 013 Control Supplement This supplement type does
not usually require new labeling. 
11/01/1984 011 Manufacturing Change or Addition This supplement type does
not usually require new labeling. 
05/31/1984 009 Package Change Label is not available
on this site. 
02/28/1984 008 Labeling Revision Label is not available
on this site. 
08/09/1983 004 Labeling Revision Label is not available
on this site. 
06/30/1983 002 Manufacturing Change or Addition This supplement type does
not usually require new labeling. 
05/07/1982 000 Approval Label is not available
on this site. 

PDF files, marked with an icon PDF file: requires free Adobe Acrobat Reader, require the free Adobe Acrobat Reader.

  • There are no Therapeutic Equivalents

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