← FDA Drug Approvals (Drugs@FDA)
MIRABEGRON
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN · Approved 2025-11-04
Drug application
- FDA Application #
ANDA218543- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MIRABEGRON
- Generic name
- MIRABEGRON
- Active ingredients
- MIRABEGRON
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MSN
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2025-11-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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