Assyro AI

FDA Orange Book · active-ingredient family

Fluconazole

Fluconazole is approved as 3 brand and 43 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DIFLUCAN · NDA 020090

3

Brand (NDA)

43

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, injectable, tablet

ProductApplicantApplicationTEApproved
DIFLUCANRLD×2PFIZERNDA 020090ABDec 23, 1993
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×6PFIZERNDA 019950—Sep 29, 1992
DIFLUCANRLD×4PFIZERNDA 019949ABJan 29, 1990

Generic (ANDA) products (43)

ProductApplicantApplicationTEApproved
FLUCONAZOLE×4FDC LTDANDA 218692ABJan 08, 2026
FLUCONAZOLE×4LUPINANDA 209146—Oct 20, 2023
FLUCONAZOLEZHEJIANG POLY PHARMANDA 215738ABSep 21, 2023
FLUCONAZOLE×4ZYDUS PHARMSANDA 208963ABFeb 16, 2017
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×3WOODWARDANDA 077909—Apr 20, 2015
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER×2HIKMA FARMACEUTICAANDA 078764—Jan 30, 2012
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2HIKMA FARMACEUTICAANDA 078698APJan 30, 2012
FLUCONAZOLE×4ANI PHARMSANDA 078423ABMar 07, 2011
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER×2WOODWARDANDA 077988—May 26, 2010
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%×2BAXTER HLTHCARE CORPANDA 077947—May 26, 2010
FLUCONAZOLE×2AUROBINDO PHARMAANDA 079150ABSep 18, 2009
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2INFORLIFEANDA 079104APJul 30, 2009
FLUCONAZOLE×4AUROBINDO PHARMAANDA 077731ABOct 07, 2008
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%×3HIKMAANDA 076087—Sep 26, 2008
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2HIKMAANDA 078107APJul 30, 2008
FLUCONAZOLE×2IVAX SUB TEVA PHARMSANDA 077523—Sep 12, 2007
FLUCONAZOLE×2TARO PHARM INDSANDA 076918—Dec 18, 2006
FLUCONAZOLE×4GLENMARK PHARMS LTDANDA 077253ABJan 25, 2006
FLUCONAZOLE×4UNIQUEANDA 076957ABSep 28, 2005
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%HIKMA FARMACEUTICAANDA 076736APAug 23, 2005
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER×2PHARMOBEDIENTANDA 076888—Mar 25, 2005
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2MYLAN LABS LTDANDA 076889—Mar 25, 2005
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2DR REDDYSANDA 076837—Jan 13, 2005
FLUCONAZOLE×2HIKMAANDA 076246—Jul 29, 2004
FLUCONAZOLE×2SUN PHARM INDS LTDANDA 076332—Jul 29, 2004
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER×2HOSPIRAANDA 076304—Jul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%×2DR REDDYSANDA 076653—Jul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%×2FRESENIUS KABI USAANDA 076145APJul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2BAXTER HLTHCAREANDA 076766APJul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2HOSPIRAANDA 076303APJul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×2HOSPIRAANDA 076617—Jul 29, 2004
FLUCONAZOLE×4ANI PHARMSANDA 076086—Jul 29, 2004
FLUCONAZOLE×4CHARTWELLANDA 076665ABJul 29, 2004
FLUCONAZOLE×4DR REDDYS LABS INCANDA 076658ABJul 29, 2004
FLUCONAZOLE×4GEDEON RICHTER USAANDA 076432—Jul 29, 2004
FLUCONAZOLE×4IVAX SUB TEVA PHARMSANDA 076077—Jul 29, 2004
FLUCONAZOLE×4MYLAN PHARMS INCANDA 076042—Jul 29, 2004
FLUCONAZOLE×4PHARMOBEDIENTANDA 076351—Jul 29, 2004
FLUCONAZOLE×4PLIVAANDA 076424—Jul 29, 2004
FLUCONAZOLE×4RANBAXY LABS LTDANDA 076386—Jul 29, 2004
FLUCONAZOLE×4ROXANEANDA 076213—Jul 29, 2004
FLUCONAZOLE×4TAROANDA 076507—Jul 29, 2004
FLUCONAZOLE×4TEVAANDA 074681—Jul 29, 2004

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.

Fluconazole — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo