← FDA Drug Approvals (Drugs@FDA)
MIRABEGRON
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUNSHINE LAKE PHARMA CO LTD · Approved 2025-12-10
Drug application
- FDA Application #
ANDA216757- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MIRABEGRON
- Generic name
- Mirabegron
- Active ingredients
- MIRABEGRON
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- SUNSHINE LAKE PHARMA CO LTD
- First approval
- 2025-12-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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