Flurbiprofen
Flurbiprofen: 1 brand, 8 generics; first approved Oct 31, 1988; generic available.
Generic available: 8 ANDA applications approved.
Brand (NDA) products
- ANSAIDRLDPHARMACIA AND UPJOHNNDA 01876619882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Generic (ANDA) products (8)
- FLURBIPROFENSUN PHARM INDS INCANDA 07505820012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLURBIPROFENTHERAGENANDA 0745601997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - FLURBIPROFENPLIVAANDA 07464719972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLURBIPROFENRISINGANDA 07444819952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLURBIPROFENRSGENUSANDA 0744311995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx — - FLURBIPROFENIVAX SUB TEVA PHARMSANDA 07441119952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - FLURBIPROFENTEVAANDA 07440519952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - FLURBIPROFENNATCO PHARMAANDA 07435819942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
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
Approvals span 1988–2001 across 9 FDA applications.
Flurbiprofen: 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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