Urso 250, Urso Forte

Treats primary biliary cholangitis (PBC). NDA 20675, held by Abbvie. Ursodiol.

As of Nov 13, 2026, NDA 20675 (Urso 250, Urso Forte), held by Abbvie, was first approved by FDA on Dec 10, 1997, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1997
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). URSO 250 and

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Jul 21, 2004	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 10, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

2 strengths and forms


Urso 250250MG · tablet;oral	Ursodiol	DiscontinuedReference drug
Urso Forte500MG · tablet;oral	Ursodiol	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jan 12, 2023	Supplement 28Labeling · Standard review	Approved	Letter Label
May 7, 2021	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 11, 2013	Supplement 25Manufacturing · Standard review	Approved	None posted
Aug 21, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 19, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 14, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 27, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 25, 2009	Supplement 17Labeling · Standard review	Approved	Label
Mar 10, 2008	Supplement 13Manufacturing	Approved	Letter Label
Sep 24, 2004	Supplement 11Labeling · Standard review	Approved	Letter
Jul 21, 2004	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 8, 2001	Supplement 7Labeling · Standard review	Approved	Letter
Mar 8, 2001	Supplement 6Manufacturing · Standard review	Approved	Letter
Feb 2, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 30, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 8, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 17, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 10, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20675
Drugs@FDA: Overview at FDA
Company: AbbVie

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