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FDA NDA · NDA019821

SORIATANE

Sponsor: STIEFEL LABS INC

APPLICATION
NDA019821
TYPE
NDA
ORIGINAL APPROVAL
1996-10-28
LATEST ACTION
2023-02-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SORIATANE · ReferenceDiscontinued
ACITRETIN 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SORIATANE · ReferenceDiscontinued
ACITRETIN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SORIATANE · ReferenceDiscontinued
ACITRETIN 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SORIATANE · ReferenceDiscontinued
ACITRETIN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2023-02-22Labeling · Supplement 29 · standard — Letter ↗AP
2017-09-27Labeling · Supplement 28 · standard — Label ↗AP
2015-05-19Labeling · Supplement 27 · standard — Label ↗AP
2014-10-28Manufacturing (CMC) · Supplement 25 · standardAP
2014-05-13Labeling · Supplement 24 · standard — Label ↗AP
2014-02-18Labeling · Supplement 22 · standard — Label ↗AP
2014-01-30Labeling · Supplement 23 · standard — Letter ↗AP
2011-11-25Labeling · Supplement 18 · unknown — Medication Guide ↗AP
2009-08-06Labeling · Supplement 17 · standard — Letter ↗AP
2007-10-18Labeling · Supplement 14 · standard — Letter ↗AP
2007-10-18Labeling · Supplement 15 · standard — Label ↗AP
2004-11-04Labeling · Supplement 12 · standard — Letter ↗AP
2004-10-08Labeling · Supplement 11 · standard — Letter ↗AP
2004-03-22Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2003-04-18Labeling · Supplement 6 · standard — Letter ↗AP
2003-04-18Labeling · Supplement 2 · standard — Review ↗AP
2003-01-03Manufacturing (CMC) · Supplement 7 · standardAP
2002-09-12Manufacturing (CMC) · Supplement 5 · standardAP
2001-01-11Manufacturing (CMC) · Supplement 4 · standardAP
1999-12-30Manufacturing (CMC) · Supplement 3 · standardAP
1997-06-05Labeling · Supplement 1 · standard — Review ↗AP
1996-10-28Type 2 - New Active Ingredient · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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