Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019821
Company: STIEFEL LABS INC
Company: STIEFEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SORIATANE | ACITRETIN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SORIATANE | ACITRETIN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SORIATANE | ACITRETIN | 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SORIATANE | ACITRETIN | 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/28/1996 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/22/2023 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019821s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019821Orig1s029ltr.pdf | |
| 09/27/2017 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019821s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019821Orig1s028ltr.pdf | |
| 05/19/2015 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019821Orig1s027ltr.pdf | |
| 10/28/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/2014 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s024ltr.pdf | |
| 01/30/2014 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s023ltr.pdf | |
| 02/18/2014 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019821Orig1s022ltr.pdf | |
| 11/25/2011 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019821s018ltr.pdf | |
| 08/06/2009 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019821s017ltr.pdf |
| 10/18/2007 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019821s014,s015ltr.pdf | |
| 10/18/2007 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019821s014,s015ltr.pdf | |
| 11/04/2004 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s012ltr.pdf |
| 10/08/2004 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821s011ltr.pdf | |
| 03/22/2004 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821scp010_soriatane_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19821scp010ltr.pdf | |
| 01/03/2003 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/2003 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019821_S002&S006_SORIATANE_AP.pdf | |
| 09/12/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/2001 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/30/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/2003 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19821slr002,006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019821_S002&S006_SORIATANE_AP.pdf | |
| 06/05/1997 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19821-S001_Soritane.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/22/2023 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019821s029lbl.pdf | |
| 09/27/2017 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019821s028lbl.pdf | |
| 09/27/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019821s028lbl.pdf | |
| 05/19/2015 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf | |
| 05/19/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019821s027lbl.pdf | |
| 05/13/2014 | SUPPL-24 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf | |
| 05/13/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s024lbl.pdf | |
| 02/18/2014 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf | |
| 02/18/2014 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf | |
| 01/30/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s023lbl.pdf | |
| 11/25/2011 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019821s018lbl.pdf | |
| 10/18/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf | |
| 10/18/2007 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019821s014s015lbl.pdf | |
| 10/08/2004 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821s011lbl.pdf | |
| 03/22/2004 | SUPPL-10 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19821scp010_soriatane_lbl.pdf | |
| 04/18/2003 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf | |
| 04/18/2003 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019821s002s006lbl.pdf |