Drug application
FLAVALTA (EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE)
Drugs@FDA NDA 216564 · DEPROCO
Key facts
| Drug name | FLAVALTA |
|---|---|
| Active ingredients | EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 216564 |
| Company | DEPROCO |
| Dosage forms | SOLUTION, INJECTION |
| Strength | EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Mar 19, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: