Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019821
Company: STIEFEL LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SORIATANE ACITRETIN 10MG CAPSULE;ORAL Prescription AB Yes No
SORIATANE ACITRETIN 25MG CAPSULE;ORAL Prescription AB Yes Yes
SORIATANE ACITRETIN 17.5MG CAPSULE;ORAL Discontinued None Yes No
SORIATANE ACITRETIN 22.5MG 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
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-Medication Guide, Labeling-Package Insert 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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019821s022lbl.pdf
02/18/2014 SUPPL-22 Labeling-Package Insert 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

SORIATANE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACITRETIN ACITRETIN 10MG CAPSULE;ORAL Prescription No AB 091455 BARR LABS INC
ACITRETIN ACITRETIN 10MG CAPSULE;ORAL Prescription No AB 202552 IMPAX LABS INC
ACITRETIN ACITRETIN 10MG CAPSULE;ORAL Prescription No AB 202148 MYLAN PHARMS INC
ACITRETIN ACITRETIN 10MG CAPSULE;ORAL Prescription No AB 204633 SIGMAPHARM LABS LLC
SORIATANE ACITRETIN 10MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACITRETIN ACITRETIN 25MG CAPSULE;ORAL Prescription No AB 091455 BARR LABS INC
ACITRETIN ACITRETIN 25MG CAPSULE;ORAL Prescription No AB 202552 IMPAX LABS INC
ACITRETIN ACITRETIN 25MG CAPSULE;ORAL Prescription No AB 202148 MYLAN PHARMS INC
ACITRETIN ACITRETIN 25MG CAPSULE;ORAL Prescription No AB 204633 SIGMAPHARM LABS LLC
SORIATANE ACITRETIN 25MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English