Details for New Drug Application (NDA): 216564
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NDA 216564 describes FLAVALTA, which is a drug marketed by Deproco and is included in one NDA. It is available from one supplier. Additional details are available on the FLAVALTA profile page.
The generic ingredient in FLAVALTA is epinephrine bitartrate; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.
The generic ingredient in FLAVALTA is epinephrine bitartrate; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.
Summary for 216564
| Tradename: | FLAVALTA |
| Applicant: | Deproco |
| Ingredient: | epinephrine bitartrate; lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216564
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 216564
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLAVALTA | epinephrine bitartrate; lidocaine hydrochloride | SOLUTION;INJECTION | 216564 | NDA | Septodont, Inc. | 0362-1200 | 0362-1200-50 | 50 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) | ||||
| Approval Date: | Mar 19, 2026 | TE: | RLD: | Yes | |||||
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