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FDA Orange Book · active-ingredient family

Fluorouracil

Fluorouracil is approved as 8 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FAVLYXA · NDA 220201

8

Brand (NDA)

42

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, injectable, solution

ProductApplicantApplicationTEApproved
FAVLYXARLDAVYXA HOLDINGSNDA 220201—Feb 20, 2026
FLUOROURACILRLD×2SPECTRUM PHARMSNDA 012209—Jul 29, 2016
TOLAKRLDHILL DERMACEUTICALSNDA 022259—Sep 18, 2015
CARACRLDEXTROVISNDA 020985—Oct 27, 2000
EFUDEXRLD×3EXTROVISNDA 016831ABApproved Prior to Jan 1, 1982
FLUOROPLEXRLDCHARTWELL RXNDA 016988—Approved Prior to Jan 1, 1982
ADRUCILRLDPHARMACIA AND UPJOHNNDA 017959—Approved Prior to Jan 1, 1982
FLUOROPLEXELORACNDA 016765—Approved Prior to Jan 1, 1982

Generic (ANDA) products (42)

ProductApplicantApplicationTEApproved
FLUOROURACILENCUBEANDA 216942ABFeb 12, 2025
FLUOROURACILKINDOSANDA 215699APFeb 06, 2025
FLUOROURACILKINDOSANDA 216494APSep 24, 2024
FLUOROURACILENCUBEANDA 215612ATNov 02, 2023
FLUOROURACILALEMBICANDA 217676APOct 18, 2023
FLUOROURACILALEMBICANDA 217295APMar 03, 2023
FLUOROURACILACCORD HLTHCAREANDA 214845ABOct 07, 2021
FLUOROURACIL×2INGENUS PHARMS LLCANDA 209219—Dec 12, 2019
FLUOROURACIL×2INGENUS PHARMS LLCANDA 209271—Dec 11, 2019
FLUOROURACIL×2GLANDANDA 210124APDec 26, 2017
FLUOROURACIL×2GLANDANDA 210123APOct 27, 2017
FLUOROURACIL×2SAGENT PHARMS INCANDA 203608APMay 11, 2017
FLUOROURACIL×2SAGENT PHARMS INCANDA 203609APFeb 17, 2016
FLUOROURACILEXTROVISANDA 203122—Apr 20, 2015
FLUOROURACIL×2EUGIA PHARMA SPECLTSANDA 202668APJul 17, 2012
FLUOROURACIL×2EUGIA PHARMA SPECLTSANDA 202669APJul 17, 2012
FLUOROURACIL×2SANDOZANDA 091299—May 02, 2011
FLUOROURACILTAROANDA 090368ABMar 05, 2010
FLUOROURACILEBEWE PHARMAANDA 040772—Aug 11, 2008
FLUOROURACILDR REDDYS LABS SAANDA 077524ABApr 11, 2008
FLUOROURACIL×2ACCORD HLTHCAREANDA 040743APApr 26, 2007
FLUOROURACIL×2ACCORD HLTHCAREANDA 040798—Apr 26, 2007
FLUOROURACIL×2TAROANDA 076526ATNov 05, 2003
FLUOROURACILFRESENIUS KABI USAANDA 040379—Nov 15, 2000
FLUOROURACIL×2TEVA PHARMS USAANDA 040334—Feb 25, 2000
FLUOROURACILTEVA PHARMS USAANDA 040333—Jan 27, 2000
FLUOROURACILFRESENIUS KABI USAANDA 040291—Mar 24, 1999
FLUOROURACIL×2FRESENIUS KABI USAANDA 040279APSep 30, 1998
FLUOROURACIL×2FRESENIUS KABI USAANDA 040278APSep 30, 1998
ADRUCILTEVA PARENTERALANDA 040023—Oct 18, 1991
ADRUCILTEVA PARENTERALANDA 081225—Aug 28, 1991
ADRUCILPHARMACIA AND UPJOHNANDA 081222—Jun 28, 1991
FLUOROURACILBEDFORDANDA 089508—Jan 26, 1988
FLUOROURACILSMITH AND NEPHEWANDA 089434—Mar 26, 1987
FLUOROURACILABRAXIS PHARMANDA 089519—Mar 12, 1987
FLUOROURACILABRAXIS PHARMANDA 089428—Jan 12, 1987
FLUOROURACILABRAXIS PHARMANDA 089152—Mar 21, 1986
FLUOROURACILABICANDA 088929—Mar 04, 1986
FLUOROURACILSMITH AND NEPHEWANDA 088766—Dec 28, 1984
FLUOROURACILSMITH AND NEPHEWANDA 088767—Dec 28, 1984
FLUOROURACILMARCHARANDA 087791—Jan 18, 1983
FLUOROURACILSPECTRUM PHARMSANDA 087792—Oct 13, 1982

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.

Fluorouracil — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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