NDA 216564, held by Deproco. Epinephrine Bitartrate; Lidocaine Hydrochloride.
As of Nov 13, 2026, NDA 216564 (Flavalta), held by Deproco, was first approved by FDA on Mar 19, 2026, with 0 approved supplements and 0 published complete response letters.
FLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FlavaltaEQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) · solution;injection | Epinephrine Bitartrate; Lidocaine Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
