Budesonide

Treats asthma. ANDA 204548, held by Teva Pharms USA. Budesonide.

As of Nov 15, 2026, ANDA 204548 (Budesonide), held by Teva Pharms USA, was first approved by FDA on Mar 8, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 8, 2016
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age Limitations of Use: Not indicated for the relief of acute bronchospasm 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 8, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Budesonide1MG/2ML · suspension;inhalation	Budesonide	Rx

All 3 submissions, including labeling and manufacturing supplements


Mar 31, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Apr 29, 2016	Supplement 1Manufacturing	Approved	None posted
Mar 8, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204548
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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