# BEMPEDOIC ACID AND EZETIMIBE
> **ANDA219421** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABORATORIES LIMITED · Approved 2025-10-23
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219421)
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