Methsuximide
Methsuximide: 1 brand, 1 generic; first approved May 01, 2023; generic available.
Generic available: 1 ANDA application approved.
Brand (NDA) products
- CELONTINRLDPARKE DAVISNDA 010596-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG CAPSULE ORAL Discontinued - 300MG CAPSULE ORAL Rx AB
Generic (ANDA) products (1)
- METHSUXIMIDENOVITIUM PHARMAANDA 2172132023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG CAPSULE ORAL Rx AB
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
All 2 applications were approved in 2023.
Methsuximide: 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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