Budesonide

For active. ANDA 205457, held by Actavis Labs Fl Inc. Budesonide.

As of Nov 15, 2026, ANDA 205457 (Budesonide), held by Actavis Labs Fl Inc, was first approved by FDA on Jul 3, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 3, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 3, 2018	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Budesonide9MG · tablet, extended release;oral	Budesonide	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 16, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Oct 10, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Jul 3, 2018	Original application	Approved	Letter

Identifiers

Application: ANDA 205457
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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