FDA Orange Book · active-ingredient family
Nabumetone
Nabumetone: 1 brand, 14 generics; first approved Dec 24, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
14
Listed patents
0
Presentations
30
Brand (NDA) products
Originator applications
- RELAFENRLDSMITHKLINE BEECHAMNDA 01958319912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- NABUMETONENOVITIUM PHARMAANDA 21911820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONERSLGM PHARMAANDA 20316620193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx — - NABUMETONESENORES PHARMSANDA 09042720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - NABUMETONEWATSON LABSANDA 09108320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONEANNORA PHARMAANDA 09044520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONEAUROBINDO PHARMA USAANDA 09051620102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - NABUMETONEOXFORD PHARMSANDA 07909320092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - NABUMETONESCIEGEN PHARMSANDA 07842020082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONEINVAGEN PHARMSANDA 07867120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONECHARTWELL MOLECULESANDA 07600920032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONECHARTWELL RXANDA 07528020022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - NABUMETONEEPIC PHARMA LLCANDA 07559020022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - NABUMETONECOPLEY PHARMANDA 0751792000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued — - NABUMETONEIMPAX LABS INCANDA 07518920002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued —
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
35 yr 4 mo ago
Most recent approval
1 yr 9 mo ago
Approvals span 1991–2025 across 15 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1493%
Nabumetone: 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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