FDA Orange Book · active-ingredient family
Felbamate
Felbamate: 1 brand, 8 generics; first approved Jul 29, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- FELBATOLRLDMYLAN SPECIALITY LPNDA 02018919933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB 600MG/5ML SUSPENSION ORAL Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- FELBAMATERSNOVITIUM PHARMAANDA 2113332019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/5ML SUSPENSION ORAL Rx AB - FELBAMATETAROANDA 2063142017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/5ML SUSPENSION ORAL Rx AB - FELBAMATEZYDUS LIFESCIENCESANDA 20897020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB - FELBAMATETAROANDA 20709320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB - FELBAMATEALVOGENANDA 20459520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued — 600MG TABLET ORAL Discontinued — - FELBAMATEANI PHARMSANDA 20228420152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB - FELBAMATEAMNEAL PHARMSANDA 2023852011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG/5ML SUSPENSION ORAL Rx AB - FELBAMATEAMNEAL PHARMSANDA 20168020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx AB 600MG TABLET ORAL Rx AB
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
7 yr 4 mo ago
Approvals span 1993–2019 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Felbamate: 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.
