FDA Orange Book · active-ingredient family
Fluorouracil
Fluorouracil: 8 brands, 42 generics; first approved Oct 13, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 42 ANDA applications approved.
Brands (NDA)
8
Generics (ANDA)
42
Listed patents
0
Presentations
69
Brand (NDA) products
Originator applications
- AVYXA HOLDINGSNDA 22020120262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/10ML (25MG/ML) SOLUTION INTRAVENOUS Rx - 2.5GM/100ML (25MG/ML) SOLUTION INTRAVENOUS Rx - - FLUOROURACILRLDSPECTRUM PHARMSNDA 01220920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Discontinued - 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Discontinued - - HILL DERMACEUTICALSNDA 0222592015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4% CREAM TOPICAL Rx - - EXTROVISNDA 0209852000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% CREAM TOPICAL Rx - - EXTROVISNDA 016831-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SOLUTION TOPICAL Rx AT 5% SOLUTION TOPICAL Discontinued - 5% CREAM TOPICAL Rx AB - FLUOROPLEXRLDCHARTWELL RXNDA 016988-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Discontinued - - ADRUCILRLDPHARMACIA AND UPJOHNNDA 017959-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - ELORACNDA 016765-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION TOPICAL Discontinued -
Generic (ANDA) products (42)
Abbreviated applications
- FLUOROURACILENCUBEANDA 2169422025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% CREAM TOPICAL Rx AB - FLUOROURACILKINDOSANDA 2156992025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILKINDOSANDA 2164942024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILENCUBEANDA 2156122023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% SOLUTION TOPICAL Rx AT - FLUOROURACILALEMBICANDA 2176762023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILRSALEMBICANDA 2172952023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILACCORD HLTHCAREANDA 2148452021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% CREAM TOPICAL Rx AB - FLUOROURACILINGENUS PHARMS LLCANDA 20921920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Discontinued - 1GM/20ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILINGENUS PHARMS LLCANDA 20927120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/100ML (50MG/ML) INJECTABLE INJECTION Discontinued - 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILGLANDANDA 21012420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Rx AP 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILGLANDANDA 21012320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Rx AP 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILSAGENT PHARMS INCANDA 20360820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Rx AP 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILSAGENT PHARMS INCANDA 20360920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Rx AP 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILEXTROVISANDA 2031222015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% CREAM TOPICAL Discontinued - - FLUOROURACILEUGIA PHARMA SPECLTSANDA 20266820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Rx AP 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILEUGIA PHARMA SPECLTSANDA 20266920122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Rx AP 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILSANDOZANDA 09129920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Discontinued - 5GM/100ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILTAROANDA 0903682010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% CREAM TOPICAL Rx AB - FLUOROURACILEBEWE PHARMAANDA 0407722008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILDR REDDYS LABS SAANDA 0775242008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% CREAM TOPICAL Rx AB - FLUOROURACILACCORD HLTHCAREANDA 04074320072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP 500MG/10ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILACCORD HLTHCAREANDA 04079820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILTAROANDA 07652620032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SOLUTION TOPICAL Rx AT 5% SOLUTION TOPICAL Rx AT - FLUOROURACILFRESENIUS KABI USAANDA 0403792000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILTEVA PHARMS USAANDA 04033420002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Discontinued - 5GM/100ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILTEVA PHARMS USAANDA 0403332000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/10ML (50MG/ML) INJECTABLE INJECTION Discontinued - - FLUOROURACILFRESENIUS KABI USAANDA 0402911999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILRSFRESENIUS KABI USAANDA 04027919982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/20ML (50MG/ML) INJECTABLE INJECTION Rx AP 500MG/10ML (50MG/ML) INJECTABLE INJECTION Rx AP - FLUOROURACILFRESENIUS KABI USAANDA 04027819982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5GM/50ML (50MG/ML) INJECTABLE INJECTION Rx AP 5GM/100ML (50MG/ML) INJECTABLE INJECTION Rx AP - TEVA PARENTERALANDA 0400231991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - TEVA PARENTERALANDA 0812251991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - PHARMACIA AND UPJOHNANDA 0812221991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILBEDFORDANDA 0895081988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILSMITH AND NEPHEWANDA 0894341987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILABRAXIS PHARMANDA 0895191987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILABRAXIS PHARMANDA 0894281987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILABRAXIS PHARMANDA 0891521986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILABICANDA 0889291986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILSMITH AND NEPHEWANDA 0887661984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILSMITH AND NEPHEWANDA 0887671984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILMARCHARANDA 0877911983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION Discontinued - - FLUOROURACILSPECTRUM PHARMSANDA 0877921982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/ML INJECTABLE INJECTION 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
44 yr 8 mo ago
Most recent approval
4 mo ago
Approvals span 1982–2026 across 50 FDA applications.
Brand (NDA) 816%
Generic (ANDA) 4284%
Fluorouracil: 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.
Assyro Intelligence
Ask anything about Fluorouracil
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo