Composition
- Active ingredients
- MIRABEGRON 8MG/ML
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 releaseThis page
- MIRABEGRON 25MG · Tablet, extended releaseANDA209488-001 · Prescription
- MIRABEGRON 50MG · Tablet, extended releaseANDA209488-002 · Prescription
- MIRABEGRON 25MG · Tablet, extended release
At a glance
- Brand name
- Mirabegron
- Route
- Oral
- Dosage form
- For suspension, extended release
- Applicant
- Alkem Labs LTD
- Status
- Prescription
- FDA approval
- 20 Jan 2026
- Application
- ANDA219323-001