Flutamide
Flutamide: 1 brand, 5 generics; first approved Jan 27, 1989; generic available.
Generic available: 5 ANDA applications approved.
Brand (NDA) products
- EULEXINRLDSCHERINGNDA 0185541989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE ORAL Discontinued -
Generic (ANDA) products (5)
- FLUTAMIDEPHARMOBEDIENTANDA 0762242003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE ORAL Discontinued - - FLUTAMIDECIPLAANDA 0757802001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE ORAL Discontinued - - FLUTAMIDEACTAVIS LABS FL INCANDA 0758202001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE ORAL Discontinued - - FLUTAMIDECHARTWELL RXANDA 0758182001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE ORAL Discontinued - - FLUTAMIDERSWAYLIS THERAPANDA 0752982001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG CAPSULE ORAL Rx -
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 1989–2003 across 6 FDA applications.
Flutamide: 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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