# MIRABEGRON
> **ANDA219323** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2026-01-20
## Drug
- **FDA Application Number:** ANDA219323
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MIRABEGRON
- **Generic name:** Mirabegron
- **Active ingredients:** MIRABEGRON
- **Dosage form:** FOR SUSPENSION, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ALKEM LABS LTD
- **First approval:** 2026-01-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219323)
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