Composition
- Active ingredients
- MIRABEGRON 50MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- MIRABEGRON 50MG · Tablet, extended releaseANDA209485-002 · Prescription
- MIRABEGRON 25MG · Tablet, extended releaseANDA209485-001 · Prescription
- MIRABEGRON 50MG · Tablet, extended releaseANDA219941-002 · Prescription
- MIRABEGRON 25MG · Tablet, extended releaseANDA219941-001 · Prescription
- MIRABEGRON 50MG · Tablet, extended releaseANDA209413-001 · Tentative approval
- MIRABEGRON 25MG · Tablet, extended releaseANDA209446-001 · Discontinued
- MIRABEGRON 25MG · Tablet, extended releaseANDA216757-002 · Tentative approval
- MIRABEGRON 25MG · Tablet, extended releaseANDA218543-001 · Prescription
- MIRABEGRON 50MG · Tablet, extended releaseANDA218543-002 · Prescription
- MIRABEGRON 8MG/ML · For suspension, extended releaseANDA219323-001 · Prescription
- MIRABEGRON 25MG · Tablet, extended releaseANDA209488-001 · Prescription
- MIRABEGRON 50MG · Tablet, extended releaseANDA209488-002 · Prescription
At a glance
- Brand name
- Mirabegron
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Sawai USA
- Status
- Discontinued
- FDA approval
- 6 May 2025
- Application
- ANDA217061-001