FDA approval · Drugs@FDA
FLAVALTAepinephrine bitartrate, lidocaine hydrochloride
NDA216564 ·
FDA approved the original new drug application for FLAVALTA on March 19, 2026, sponsored by DEPROCO. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA216564
- Sponsor
- DEPROCO
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- epinephrine bitartrate, lidocaine hydrochloride
Browse every approval whose brand starts with F, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| epinephrine bitartrate EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML); lidocaine hydrochloride 34MG/1.7ML (20MG/ML) | SOLUTION | INJECTION | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to DEPROCO
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