Soriatane

NDA 19821, held by Stiefel Labs Inc. Acitretin.

As of Nov 14, 2026, NDA 19821 (Soriatane), held by Stiefel Labs Inc, was first approved by FDA on Oct 28, 1996, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 28, 1996
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Oct 28, 1996	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

4 strengths and forms


Soriatane10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Acitretin	DiscontinuedReference drug
Soriatane25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Acitretin	DiscontinuedReference drug
Soriatane17.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Acitretin	DiscontinuedReference drug
Soriatane22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Acitretin	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Feb 22, 2023	Supplement 29Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 27, 2017	Supplement 28Labeling · Standard review	Approved	Letter Label
May 19, 2015	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 28, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
May 13, 2014	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 18, 2014	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 30, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Nov 25, 2011	Supplement 18Labeling	Approved	Label Medication Guide Letter
Aug 6, 2009	Supplement 17Labeling · Standard review	Approved	Letter
Oct 18, 2007	Supplement 15Labeling · Standard review	Approved	Letter Label
Oct 18, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Nov 4, 2004	Supplement 12Labeling · Standard review	Approved	Letter
Oct 8, 2004	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 22, 2004	Supplement 10Manufacturing · Standard review	Approved	Label Letter
Apr 18, 2003	Supplement 6Labeling · Standard review	Approved	Review Letter Label
Apr 18, 2003	Supplement 2Labeling · Standard review	Approved	Review Letter Label
Jan 3, 2003	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 12, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 11, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 30, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 5, 1997	Supplement 1Labeling · Standard review	Approved	Review
Oct 28, 1996	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19821
Drugs@FDA: Overview at FDA
Company: Stiefel Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters