FDA Orange Book · active-ingredient family
Epinephrine bitartrate; lidocaine hydrochloride
Epinephrine bitartrate; lidocaine hydrochloride is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FLAVALTA · NDA 216564
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLAVALTARLD | DEPROCO | NDA 216564 | — | Mar 19, 2026 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIGNOSPAN FORTERLD | DEPROCO | ANDA 088389 | — | Jan 22, 1985 | |
| LIGNOSPAN STANDARDRLD | DEPROCO | ANDA 088390 | — | Jan 22, 1985 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Epinephrine bitartrate; lidocaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
