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SORIATANE

NDA

ACITRETIN | N019821 | STIEFEL LABORATORIES INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAACITRETIN

DMF 170012003

SOLARA ACTIVE PHARMA SCIENCES LTDACITRETIN

DMF 223582008

USV PRIVATE LTDACITRETIN USP

DMF 233102009

OLON SPAACITRETIN (FORM I)

DMF 244302010

CHONGQING HUAPONT PHARMACEUTICAL CO LTDACITRETIN

DMF 246212011

GLOPEC INTERNATIONAL INCACITRETIN

DMF 261822012

SUN PHARMACEUTICAL INDUSTRIES LTDACITRETIN USP

DMF 288962014

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveACITRETIN USP

DMF 165802003

BASF SEInactiveACITRETIN

DMF 220902008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2023	SUPPL -29	View Letter (PDF)
Sep 29, 2017	SUPPL -28	View Letter (PDF)
May 22, 2015	SUPPL -27	View Letter (PDF)
May 19, 2014	SUPPL -24	View Letter (PDF)
Feb 20, 2014	SUPPL -22	View Letter (PDF)
Feb 4, 2014	SUPPL -23	View Letter (PDF)
Nov 28, 2011	SUPPL -18	View Letter (PDF)
Feb 16, 2010	SUPPL -17	View Letter (PDF)
Oct 22, 2007	SUPPL -15	View Letter (PDF)
Oct 22, 2007	SUPPL -14	View Letter (PDF)
Nov 8, 2004	SUPPL -12	View Letter (PDF)
Oct 15, 2004	SUPPL -11	View Letter (PDF)
Mar 24, 2004	SUPPL -10	View Letter (PDF)
May 29, 2003	SUPPL -2	View Letter (PDF)
May 29, 2003	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 28, 1996

No patent or exclusivity listings for this strength.

#002 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 28, 1996

#003 — 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 6, 2009

#004 — 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 6, 2009