# RANOLAZINE
> **ANDA214551** · Abbreviated New Drug Application (Generic) · Sponsor: UMEDICA · Approved 2026-08-05
## Drug
- **FDA Application Number:** ANDA214551
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** RANOLAZINE
- **Generic name:** RANOLAZINE
- **Active ingredients:** RANOLAZINE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** UMEDICA
- **Manufacturer:** Umedica Laboratories USA Inc.
- **First approval:** 2026-08-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214551)
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