# FLAVALTA
> **NDA216564** · New Drug Application · Sponsor: DEPROCO · Approved 2026-03-19
## Drug
- **FDA Application Number:** NDA216564
- **Application type:** New Drug Application
- **Brand name:** FLAVALTA
- **Generic name:** LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
- **Active ingredients:** EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** DEPROCO
- **Manufacturer:** Septodont, Inc.
- **First approval:** 2026-03-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216564)
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