Levonordefrin; mepivacaine hydrochloride
Levonordefrin; mepivacaine hydrochloride: 1 brand, 5 generics; first approved Oct 21, 1983; generic available.
Generic available: 5 ANDA applications approved.
Brand (NDA) products
- EASTMAN KODAKNDA 012125-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML;2% INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (5)
- DENTSPLY PHARMANDA 0895171988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML;2% INJECTABLE INJECTION Discontinued - - DEPROCOANDA 0883881984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML;2% INJECTABLE INJECTION Discontinued - - BELMORA LLCANDA 0848501983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML;2% INJECTABLE INJECTION Discontinued - - SOLVAYANDA 085010-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML;2% INJECTABLE INJECTION Discontinued - - SEPTODONTANDA 084697-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/ML;2% INJECTABLE INJECTION Discontinued -
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.
Approval history
Approvals span 1983–1988 across 6 FDA applications.
Levonordefrin; mepivacaine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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