Is there a generic for Ketoconazole?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Ketoconazole, referencing the brand EXTINA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ketoconazole?

EXTINA (NDA 021738, RISING) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Ketoconazole are approved?

Ketoconazole is approved in the following dosage forms: aerosol, foam, cream, gel, shampoo, suspension, tablet.

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)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

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EXTINARLD
RISINGNDA 0217382007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% AEROSOL, FOAM TOPICAL Discontinued -
XOLEGELRLD
INA PHARMSNDA 0219462006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% GEL TOPICAL Discontinued -
NIZORAL ANTI-DANDRUFFRLDRS
KRAMERNDA 0203101997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL OTC -
NIZORALRLD
JANSSEN PHARMSNDA 0199271990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SHAMPOO TOPICAL Discontinued -
NIZORALRLD
JANSSEN PHARMANDA 0190841985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM TOPICAL Discontinued -
NIZORALRLD
JANSSEN PHARMSNDA 018533-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	AEROSOL, FOAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	GEL	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	OTC	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SHAMPOO	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Generic (ANDA) products (22)

Abbreviated applications

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KETOCONAZOLE
NOVITIUM PHARMAANDA 2191292025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Rx AB
KETOCONAZOLE
ZYDUS LIFESCIENCESANDA 2185592025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SHAMPOO TOPICAL Rx AB
KETOCONAZOLE
NOVITIUM PHARMAANDA 2184982024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SHAMPOO TOPICAL Rx AB
KETOCONAZOLE
PADAGIS USANDA 2151852021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM TOPICAL Discontinued -
KETOCONAZOLERS
XIROMEDANDA 2136012021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% AEROSOL, FOAM TOPICAL Rx AB
KETOCONAZOLERS
ENCUBEANDA 2124432021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM TOPICAL Rx AB
KETOCONAZOLE
STRIDES PHARMAANDA 2104572018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Rx AB
KETOCONAZOLE
PADAGIS ISRAELANDA 0915502011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% AEROSOL, FOAM TOPICAL Rx AB
KETOCONAZOLE
COSETTE PHARMS NCANDA 0769422005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SHAMPOO TOPICAL Rx AB
KETOCONAZOLE
FOUGERA PHARMSANDA 0762942004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM TOPICAL Rx AB
KETOCONAZOLERS
PADAGIS ISRAELANDA 0764192004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SHAMPOO TOPICAL Rx AB
KETOZOLE
SUN PHARMA CANADAANDA 0756382002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM TOPICAL Rx AB
KETOCONAZOLE
SENORES PHARMSANDA 0759122002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Rx AB
KETOCONAZOLE
TEVAANDA 0755812000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM TOPICAL Rx AB
KETOCONAZOLE
AUROBINDO PHARMA USAANDA 0755971999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
KETOCONAZOLE
AAIPHARMA LLCANDA 0753411999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
KETOCONAZOLE
CHARTWELL RXANDA 0749711999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
KETOCONAZOLE
HERITAGE PHARMAANDA 0753621999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
KETOCONAZOLE
SUN PHARM INDUSTRIESANDA 0753141999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
KETOCONAZOLERS
TAROANDA 0753191999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Rx AB
KETOCONAZOLE
TEVAANDA 0752731999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
NIZORAL
JANSSEN PHARMAANDA 0707671986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG/5ML SUSPENSION ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SHAMPOO	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SHAMPOO	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	AEROSOL, FOAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	AEROSOL, FOAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SHAMPOO	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SHAMPOO	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	-

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

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First approval

Dec 31, 1985

41 yr 5 mo ago

Most recent approval

Jul 03, 2025

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

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