FDA Orange Book · active-ingredient family
Levonordefrin; mepivacaine hydrochloride
Levonordefrin; mepivacaine hydrochloride is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CARBOCAINE W/ NEO-COBEFRIN · NDA 012125
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARBOCAINE W/ NEO-COBEFRIN | EASTMAN KODAK | NDA 012125 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POLOCAINE W/ LEVONORDEFRIN | DENTSPLY PHARM | ANDA 089517 | — | Apr 14, 1988 | |
| SCANDONEST L | DEPROCO | ANDA 088388 | — | Oct 10, 1984 | |
| MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN | BELMORA LLC | ANDA 084850 | — | Oct 21, 1983 | |
| ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN | SOLVAY | ANDA 085010 | — | Approved Prior to Jan 1, 1982 | |
| ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN | SEPTODONT | ANDA 084697 | — | Approved Prior to Jan 1, 1982 |
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.
Levonordefrin; mepivacaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
