FDA Orange Book · active-ingredient family
Diflunisal
Diflunisal: 1 brand, 9 generics; first approved Apr 19, 1982; 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
15
Brand (NDA) products
Originator applications
- DOLOBIDRLDMERCKNDA 01844519822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- DIFLUNISALHERITAGE PHARMAANDA 20284520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB 250MG TABLET ORAL Rx — 375MG TABLET ORAL Rx — - DIFLUNISALZYDUS PHARMSANDA 2035472017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AB - DIFLUNISALWATSON LABSANDA 07440019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - DIFLUNISALANI PHARMSANDA 0746041996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - DIFLUNISALPUREPAC PHARMANDA 07428519962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - DIFLUNISALDASTECH INTLANDA 0735621992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - DIFLUNISALDASTECH INTLANDA 0735631992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — - DIFLUNISALTEVAANDA 0736791992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — - DIFLUNISALRSTEVAANDA 0736731992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG 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
45 yr ago
Most recent approval
2 yr 1 mo ago
Approvals span 1982–2024 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Diflunisal: 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.
