Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018662
Company: HOFFMANN LA ROCHE
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| ACCUTANE | ISOTRETINOIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ACCUTANE | ISOTRETINOIN | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| ACCUTANE | ISOTRETINOIN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |