FDA Orange Book · active-ingredient family
Ethosuximide
Ethosuximide: 1 brand, 9 generics; first approved Jul 30, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- PARKE DAVISNDA 012380—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- ETHOSUXIMIDEPURACAP PHARM LLCANDA 2106542020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - ETHOSUXIMIDEONESOURCE SPECIALTYANDA 2119282019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - ETHOSUXIMIDEHERITAGE PHARMS INCANDA 2008922012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — - ETHOSUXIMIDEEPIC PHARMA LLCANDA 0406862008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - ETHOSUXIMIDECHARTWELL RXANDA 0405062003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SYRUP ORAL Rx AA - ETHOSUXIMIDEBIONPHARMAANDA 0404302002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB - ETHOSUXIMIDEPHARM ASSOCANDA 0402532000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SYRUP ORAL Rx AA - ETHOSUXIMIDETEVA PHARMSANDA 0813061993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SYRUP ORAL Discontinued — - PARKE-DAVISANDA 080258—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SYRUP ORAL Rx AA
Listed patents
Orange Book patent file
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
FDA approval span
First approval
33 yr 6 mo ago
Most recent approval
6 yr 6 mo ago
Approvals span 1993–2020 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Ethosuximide: 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.
