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Medicines · US (FDA)
Corticosteroids

FDA 2016

Corticosteroids acting locally

Budesonide

Approved 8 Apr 2016OralCapsule, delayed release

The FDA lists this product in 31 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: BUDESONIDE 3MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

BUDESONIDE 0.032MG/INH · Spray, meteredANDA078949-001 · Prescription
BUDESONIDE 0.032MG/SPRAY · Spray, meteredANDA078949-002 · Over the counter
BUDESONIDE 0.25MG/2ML · SuspensionANDA077519-001 · Prescription
BUDESONIDE 0.5MG/2ML · SuspensionANDA077519-002 · Prescription
BUDESONIDE 0.5MG/2ML · SuspensionANDA078404-002 · Prescription
BUDESONIDE 0.25MG/2ML · SuspensionANDA078404-001 · Prescription
BUDESONIDE 3MG · Capsule, delayed releaseThis page
BUDESONIDE 9MG · Tablet, extended releaseANDA205457-001 · Prescription
BUDESONIDE 0.5MG/2ML · SuspensionANDA211922-002 · Prescription
BUDESONIDE 1MG/2ML · SuspensionANDA211922-003 · Prescription
BUDESONIDE 0.25MG/2ML · SuspensionANDA211922-001 · Prescription
BUDESONIDE 0.5MG/2ML · Suspension

More in corticosteroids

Budesonide and Formoterol Fumarate Dihydratebudesonide · Aerosol, metered
Ciprofloxacin Hydrochloride and Hydrocortisoneciprofloxacin hydrochloride · Suspension/drops

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA216667-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA206200-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA090379-001 · Discontinued

BUDESONIDE 0.5MG/2ML · SuspensionANDA201966-002 · Discontinued

BUDESONIDE 0.25MG/2ML · SuspensionANDA201966-003 · Discontinued

BUDESONIDE 1MG/2ML · SuspensionANDA201966-001 · Discontinued

BUDESONIDE 0.5MG/2ML · SuspensionANDA205710-002 · Prescription

BUDESONIDE 1MG/2ML · SuspensionANDA205710-003 · Prescription

BUDESONIDE 0.25MG/2ML · SuspensionANDA205710-001 · Prescription

BUDESONIDE 0.5MG/2ML · SuspensionANDA210897-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA206724-001 · Discontinued

BUDESONIDE 9MG · Tablet, extended releaseANDA208851-001 · Prescription

BUDESONIDE 0.5MG/2ML · SuspensionANDA078202-002 · Prescription

BUDESONIDE 0.25MG/2ML · SuspensionANDA078202-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA090410-001 · Prescription

BUDESONIDE 1MG/2ML · SuspensionANDA204548-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA206134-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA207367-001 · Prescription

BUDESONIDE 3MG · Capsule, delayed releaseANDA209041-001 · Discontinued

BUDESONIDE 2MG/ACTUATION · Aerosol, foamANDA215328-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA206623.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Budesonide
Drug class: Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
Group: Corticosteroids
Route: Oral
Dosage form: Capsule, delayed release
Applicant: DR Reddys Labs SA
Status: Prescription
FDA approval: 8 Apr 2016
Application: ANDA206623-001
RxCUI: 19831

Guidelines

Guidelines in endocrinology and metabolism950 guidelines in the library

FDA 2025

Pyquvideflazacort · Suspension

FDA 2025Khindivihydrocortisone · Solution

FDA 2025Jaytharideflazacort · Tablet

FDA 2024DeflazacortSuspension

FDA 2024Eohiliabudesonide · Suspension

FDA 2024TacrolimusCapsule, extended release

FDA 2024FluorometholoneSuspension/drops

FDA 2023Airsupraalbuterol sulfate · Aerosol, metered

FDA 2021Tarpeyobudesonide · Capsule, delayed release

FDA 2021Oxymetazoline HydrochlorideCream

FDA 2021DifluprednateEmulsion

FDA 2021Formoterol FumarateSolution

FDA 2020Alkindi Sprinklehydrocortisone · Granule

FDA 2020Ciprofloxacin and Dexamethasoneciprofloxacin · Suspension/drops

FDA 2020Breztri Aerospherebudesonide · Aerosol, metered

FDA 2020Wynzorabetamethasone dipropionate · Cream