FDA Orange Book · active-ingredient family
Fluconazole
Fluconazole: 3 brands, 43 generics; first approved Jan 29, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 43 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
43
Listed patents
0
Presentations
136
Brand (NDA) products
Originator applications
- DIFLUCANRLDPFIZERNDA 02009019932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - PFIZERNDA 01995019926 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - DIFLUCANRLDPFIZERNDA 01994919904 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB
Generic (ANDA) products (43)
Abbreviated applications
- FLUCONAZOLEFDC LTDANDA 21869220264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - FLUCONAZOLELUPINANDA 20914620234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLEZHEJIANG POLY PHARMANDA 2157382023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Rx AB - FLUCONAZOLEZYDUS PHARMSANDA 20896320174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - WOODWARDANDA 07790920153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP 100MG/50ML (2MG/ML) INJECTABLE INJECTION Rx - - HIKMA FARMACEUTICAANDA 07876420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - HIKMA FARMACEUTICAANDA 07869820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - FLUCONAZOLEANI PHARMSANDA 07842320114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - WOODWARDANDA 07798820102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - BAXTER HLTHCARE CORPANDA 07794720102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - FLUCONAZOLEAUROBINDO PHARMAANDA 07915020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - INFORLIFEANDA 07910420092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - FLUCONAZOLEAUROBINDO PHARMAANDA 07773120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - HIKMAANDA 07608720083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 100MG/50ML (2MG/ML) INJECTABLE INJECTION Rx - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - HIKMAANDA 07810720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - FLUCONAZOLEIVAX SUB TEVA PHARMSANDA 07752320072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML FOR SUSPENSION ORAL Discontinued - 200MG/5ML FOR SUSPENSION ORAL Discontinued - - FLUCONAZOLETARO PHARM INDSANDA 07691820062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML FOR SUSPENSION ORAL Discontinued - 200MG/5ML FOR SUSPENSION ORAL Discontinued - - FLUCONAZOLEGLENMARK PHARMS LTDANDA 07725320064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - FLUCONAZOLEUNIQUEANDA 07695720054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - HIKMA FARMACEUTICAANDA 0767362005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP - PHARMOBEDIENTANDA 07688820052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - MYLAN LABS LTDANDA 07688920052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - DR REDDYSANDA 07683720052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - FLUCONAZOLEHIKMAANDA 07624620042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML FOR SUSPENSION ORAL Discontinued - 200MG/5ML FOR SUSPENSION ORAL Discontinued - - FLUCONAZOLESUN PHARM INDS LTDANDA 07633220042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML FOR SUSPENSION ORAL Discontinued - 200MG/5ML FOR SUSPENSION ORAL Discontinued - - HOSPIRAANDA 07630420042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - DR REDDYSANDA 07665320042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - FRESENIUS KABI USAANDA 07614520042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - BAXTER HLTHCAREANDA 07676620042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - HOSPIRAANDA 07630320042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Rx AP 400MG/200ML (2MG/ML) INJECTABLE INJECTION Rx AP - HOSPIRAANDA 07661720042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML (2MG/ML) INJECTABLE INJECTION Discontinued - 400MG/200ML (2MG/ML) INJECTABLE INJECTION Discontinued - - FLUCONAZOLEANI PHARMSANDA 07608620044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLECHARTWELLANDA 07666520044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - FLUCONAZOLEDR REDDYS LABS INCANDA 07665820044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB - FLUCONAZOLEGEDEON RICHTER USAANDA 07643220044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLEIVAX SUB TEVA PHARMSANDA 07607720044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLEMYLAN PHARMS INCANDA 07604220044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLEPHARMOBEDIENTANDA 07635120044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLEPLIVAANDA 07642420044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLERANBAXY LABS LTDANDA 07638620044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLEROXANEANDA 07621320044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLETAROANDA 07650720044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL Discontinued - - FLUCONAZOLETEVAANDA 07468120044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 100MG TABLET ORAL Discontinued - 150MG TABLET ORAL Discontinued - 200MG TABLET ORAL 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
37 yr 3 mo ago
Most recent approval
10 mo ago
Approvals span 1990–2026 across 46 FDA applications.
Brand (NDA) 37%
Generic (ANDA) 4393%
Fluconazole: 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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