FDA Orange Book · active-ingredient family
Ketoconazole
Ketoconazole: 6 brands, 22 generics; first approved Dec 31, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
22
Listed patents
0
Presentations
28
Brand (NDA) products
Originator applications
- EXTINARLDRISINGNDA 0217382007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% AEROSOL, FOAM TOPICAL Discontinued — - XOLEGELRLDINA PHARMSNDA 0219462006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% GEL TOPICAL Discontinued — - KRAMERNDA 0203101997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SHAMPOO TOPICAL OTC — - NIZORALRLDJANSSEN PHARMSNDA 0199271990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SHAMPOO TOPICAL Discontinued — - NIZORALRLDJANSSEN PHARMANDA 0190841985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Discontinued — - NIZORALRLDJANSSEN PHARMSNDA 018533—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- KETOCONAZOLENOVITIUM PHARMAANDA 2191292025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - KETOCONAZOLEZYDUS LIFESCIENCESANDA 2185592025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SHAMPOO TOPICAL Rx AB - KETOCONAZOLENOVITIUM PHARMAANDA 2184982024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SHAMPOO TOPICAL Rx AB - KETOCONAZOLEPADAGIS USANDA 2151852021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Discontinued — - KETOCONAZOLERSXIROMEDANDA 2136012021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% AEROSOL, FOAM TOPICAL Rx AB - KETOCONAZOLERSENCUBEANDA 2124432021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Rx AB - KETOCONAZOLESTRIDES PHARMAANDA 2104572018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - KETOCONAZOLEPADAGIS ISRAELANDA 0915502011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% AEROSOL, FOAM TOPICAL Rx AB - KETOCONAZOLECOSETTE PHARMS NCANDA 0769422005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SHAMPOO TOPICAL Rx AB - KETOCONAZOLEFOUGERA PHARMSANDA 0762942004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Rx AB - KETOCONAZOLERSPADAGIS ISRAELANDA 0764192004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% SHAMPOO TOPICAL Rx AB - SUN PHARMA CANADAANDA 0756382002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Rx AB - KETOCONAZOLESENORES PHARMSANDA 0759122002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - KETOCONAZOLETEVAANDA 0755812000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% CREAM TOPICAL Rx AB - KETOCONAZOLEAUROBINDO PHARMA USAANDA 0755971999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - KETOCONAZOLEAAIPHARMA LLCANDA 0753411999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - KETOCONAZOLECHARTWELL RXANDA 0749711999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - KETOCONAZOLEHERITAGE PHARMAANDA 0753621999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - KETOCONAZOLESUN PHARM INDUSTRIESANDA 0753141999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - KETOCONAZOLERSTAROANDA 0753191999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - KETOCONAZOLETEVAANDA 0752731999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - JANSSEN PHARMAANDA 0707671986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML SUSPENSION 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
41 yr 4 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 1985–2025 across 28 FDA applications.
Brand (NDA) 621%
Generic (ANDA) 2279%
Ketoconazole: 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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