Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018662
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCUTANE ISOTRETINOIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
ACCUTANE ISOTRETINOIN 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
ACCUTANE ISOTRETINOIN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/07/1982 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/22/2010 SUPPL-61 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018662s061ltr.pdf
02/01/2010 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018662s060ltr.pdf
11/19/2008 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018662s059ltr.pdf
10/03/2007 SUPPL-58 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018662s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018662s058ltr.pdf
01/13/2006 SUPPL-57 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018662_S057_ACCUTANE_AP.pdf
08/12/2005 SUPPL-56 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018662s056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018662_S056_ACCUTANE_AP.pdf
08/10/2005 SUPPL-55 Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018662_S055_ACCUTANE_AP.pdf
08/24/2004 SUPPL-54 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18662s054ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018662_S054_ACCUTANE_AP.pdf
03/26/2004 SUPPL-53 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018662_S053_ACCUTANE_AP.pdf
08/27/2003 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18662slr048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018662_S052_ACCUTANE_AP.pdf
06/20/2002 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s051LTR.pdf
08/27/2003 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18662slr048,052ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018662_S048_ACCUTANE_AP.pdf
04/12/2002 SUPPL-47 Labeling Letter (PDF)
Patient Package Insert (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s47ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s47Pi.pdf
02/15/2002 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s046ltr.pdf
12/31/2001 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s41s45ltr.pdf
10/30/2001 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s44lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s44ltr.pdf
05/02/2002 SUPPL-43 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s043ltr.pdf
01/11/2001 SUPPL-42 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018662_S042_ACCUTANE_AP.pdf
12/31/2001 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s41s45ltr.pdf
05/01/2000 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s40ltr.pdf
05/01/2000 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s39ltr.pdf
05/01/2000 SUPPL-38 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s38ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018662_S038_ACCUTANE_AP.pdf
04/30/1999 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/17/1995 SUPPL-34 Labeling

Label is not available on this site.

01/13/1994 SUPPL-33 Labeling

Label is not available on this site.

10/08/1991 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1990 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/07/1991 SUPPL-30 Labeling

Label is not available on this site.

04/16/1990 SUPPL-29 Labeling

Label is not available on this site.

08/09/1989 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/1989 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/28/1989 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/16/1988 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/1988 SUPPL-24 Labeling

Label is not available on this site.

01/07/1988 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/19/1987 SUPPL-22 Labeling

Label is not available on this site.

06/03/1987 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1987 SUPPL-20 Labeling

Label is not available on this site.

02/26/1987 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/06/1986 SUPPL-18 Labeling

Label is not available on this site.

06/06/1986 SUPPL-17 Labeling

Label is not available on this site.

07/05/1985 SUPPL-16 Labeling

Label is not available on this site.

04/30/1985 SUPPL-15 Labeling

Label is not available on this site.

06/06/1986 SUPPL-14 Efficacy-New Dosing Regimen

Label is not available on this site.

11/27/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/06/1986 SUPPL-10 Labeling

Label is not available on this site.

05/31/1984 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1984 SUPPL-8 Labeling

Label is not available on this site.

06/19/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1983 SUPPL-4 Labeling

Label is not available on this site.

06/06/1986 SUPPL-3 Labeling

Label is not available on this site.

06/30/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/06/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2010 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf
11/19/2008 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf
10/03/2007 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018662s058lbl.pdf
08/12/2005 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf
08/24/2004 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf
08/27/2003 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf
08/27/2003 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf
06/20/2002 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf
05/02/2002 SUPPL-43 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s043lbl.pdf
02/15/2002 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s046lbl.pdf
12/31/2001 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf
12/31/2001 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf
10/30/2001 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s44lbl.pdf

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