Budesonide

As of Nov 15, 2026, ANDA 78949 (Budesonide), held by Apotex, was first approved by FDA on May 12, 2014, with 2 approved supplements and 0 published complete response letters.

First approved: May 12, 2014
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

nasal congestion
runny nose
itchy nose
sneezing

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
May 12, 2014	Original application	Approved	None posted

Products

2 strengths and forms


Budesonide0.032MG/INH · spray, metered;nasal	Budesonide	Rx
Budesonide0.032MG/SPRAY · spray, metered;nasal	Budesonide	OTC

All 3 submissions, including labeling and manufacturing supplements


Oct 29, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 20, 2015	Supplement 3Labeling · Standard review	Approved	None posted
May 12, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 78949
Drugs@FDA: Overview at FDA
Company: Apotex

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