FDA Orange Book · active-ingredient family
Flucytosine
Flucytosine: 1 brand, 7 generics; first approved Jun 28, 2011; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- ANCOBONRLDBAUSCHNDA 017001—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB
Generic (ANDA) products (7)
Abbreviated applications
- FLUCYTOSINELAURUSANDA 21800520252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - FLUCYTOSINEAUROBINDO PHARMA LTDANDA 21366520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - FLUCYTOSINESTRIDES PHARMAANDA 21263220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - FLUCYTOSINESTRIDES PHARMAANDA 20753620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - FLUCYTOSINEHIKMAANDA 20655020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Discontinued — 500MG CAPSULE ORAL Discontinued — - FLUCYTOSINENOVEL LABS INCANDA 20465220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE ORAL Rx AB - FLUCYTOSINESIGMAPHARM LABS LLCANDA 20156620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE ORAL Rx AB 500MG CAPSULE 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
15 yr 4 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 2011–2025 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Flucytosine: 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.
