# MIRABEGRON
> **ANDA218543** · Abbreviated New Drug Application (Generic) · Sponsor: MSN · Approved 2025-11-04
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218543)
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