Budesonide

Treats asthma. ANDA 78202, held by Nephron. Budesonide.

As of Nov 15, 2026, ANDA 78202 (Budesonide), held by Nephron, was first approved by FDA on Mar 30, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 30, 2009
Supplements approved: 1
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 2 submissions below

Date	Submission	Status	Documents
Mar 30, 2009	Original application	Approved	Review

Products

2 strengths and forms


Budesonide0.25MG/2ML · suspension;inhalation	Budesonide	Rx
Budesonide0.5MG/2ML · suspension;inhalation	Budesonide	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 30, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 30, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 78202
Drugs@FDA: Overview at FDA
Company: Nephron Pharmaceuticals Corp.

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