← FDA Drug Approvals (Drugs@FDA)
BEMPEDOIC ACID AND EZETIMIBE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABORATORIES LIMITED · Approved 2025-10-23
Drug application
- FDA Application #
ANDA219421- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BEMPEDOIC ACID AND EZETIMIBE
- Generic name
- Bempedoic Acid, Ezetimibe
- Active ingredients
- BEMPEDOIC ACID, EZETIMIBE
- Dosage form
- TABLET
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- ALKEM LABORATORIES LIMITED
- First approval
- 2025-10-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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