Composition
- Active ingredients
- BUDESONIDE 9MG
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 releaseANDA206623-001 · Prescription
- 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 · SuspensionANDA216667-001 · Prescription
- BUDESONIDE 3MG · Capsule, delayed releaseANDA206200-001 · Prescription
At a glance
- Brand name
- Budesonide
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Mylan
- Status
- Prescription
- FDA approval
- 17 Sept 2020
- Application
- ANDA208851-001