Is there a generic for Fluocinonide?

Yes. The FDA Orange Book lists 41 approved generic (ANDA) applications for Fluocinonide, referencing the brand VANOS. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fluocinonide?

VANOS (NDA 021758, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Fluocinonide are approved?

Fluocinonide is approved in the following dosage forms: cream, gel, ointment, solution.

FDA Orange Book · active-ingredient family

Fluocinonide

Fluocinonide: 6 brands, 41 generics; first approved Apr 06, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 41 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

VANOSRLDRS

BAUSCHNDA 0217582005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB

FLUOCINONIDERLD

SUN PHARMA CANADANDA 0191171984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM	TOPICAL	Discontinued	—

LIDEXRLD

ALVOGENNDA 0188491984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	TOPICAL	Discontinued	—

LIDEXRLD

ALVOGENNDA 016908—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM	TOPICAL	Discontinued	—
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM	TOPICAL	Discontinued	—

FLUOCINONIDERLD

ALVOGENNDA 017373—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL	TOPICAL	Discontinued	—

LIDEXRLD

ALVOGENNDA 016909—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT	TOPICAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (41)

FLUOCINONIDE

QUAGENANDA 2163892025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

ZYDUS LIFESCIENCESANDA 2089892020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB

FLUOCINONIDE

XIROMEDANDA 2129762019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

FLUOCINONIDE

ENCUBEANDA 2117582019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	—

FLUOCINONIDE

SCIEGEN PHARMSANDA 2075542019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

ENCUBE ETHICALSANDA 2096992018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

ENCUBEANDA 2114102018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

FLUOCINONIDE

PAI HOLDINGS PHARMANDA 2076802018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Discontinued	—

FLUOCINONIDERS

AMNEALANDA 2105542018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

FLUOCINONIDE

ZYDUS PHARMSANDA 2089482018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

PADAGIS USANDA 2090302018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Rx	AB

FLUOCINONIDE

AMNEALANDA 2111112018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	—

FLUOCINONIDE

CHARTWELL RXANDA 2091182018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

MACLEODS PHARMS LTDANDA 2092832018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

CHARTWELL RXANDA 2075382017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

FLUOCINONIDE

NOVEL LABS INCANDA 2060032017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

FOUGERA PHARMS INCANDA 2007352014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB

FLUOCINONIDE

GLENMARK PHARMS LTDANDA 0912822014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	—

FLUOCINONIDE

SUN PHARMA CANADAANDA 2007342014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Rx	AB

FLUOCINONIDE

PADAGIS ISRAELANDA 0902562014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	CREAM	TOPICAL	Discontinued	—

FLUOCINONIDE EMULSIFIED BASE

FOUGERA PHARMSANDA 0765862004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB2

FLUOCINONIDERS

SUN PHARMA CANADAANDA 0750081999

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

FLUOCINONIDE

FOUGERA PHARMSANDA 0749051997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

FLUOCINONIDERS

SUN PHARMA CANADAANDA 0749351997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Rx	AB

FLUOCINONIDERS

SUN PHARMA CANADAANDA 0747991996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE EMULSIFIED BASE

COSETTE PHARMS NCANDA 0742041995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB2

FLUOCINONIDE

FOUGERA PHARMS INCANDA 0729341995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Rx	AT

FLUOCINONIDE

FOUGERA PHARMS INCANDA 0729331994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Rx	AB

FLUOCINONIDE

FOUGERA PHARMS INCANDA 0730301994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

FLUOCINONIDE

COSETTE PHARMS NCANDA 0730851992

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

FLUOCINONIDE

TEVAANDA 0734811991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	OINTMENT	TOPICAL	Rx	AB

FLUOCINONIDE

TEVA PHARMSANDA 0725221990

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Discontinued	—

FLUOCINONIDE

SUN PHARMA CANADAANDA 0728571989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Discontinued	—

FLUOCINONIDE EMULSIFIED BASE

TEVAANDA 0724901989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB2

FLUOCINONIDE

COSETTEANDA 0725371989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	GEL	TOPICAL	Discontinued	—

FLUOCINONIDE

TEVAANDA 0725111989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Discontinued	—

FLUOCINONIDE

TEVAANDA 0724881989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

FLUOCINONIDE EMULSIFIED BASERS

TAROANDA 0724941989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB2

FLUOCINONIDE

COSETTEANDA 0715351988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	SOLUTION	TOPICAL	Discontinued	—

FLUOCINONIDE

PERRIGO NEW YORKANDA 0717901988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Discontinued	—

FLUOCINONIDE

SUN PHARMA CANADAANDA 0715001987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05%	CREAM	TOPICAL	Rx	AB1

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Apr 06, 1984

42 yr 11 mo ago

Most recent approval

Feb 26, 2025

1 yr 5 mo ago

Approvals span 1984–2025 across 47 FDA applications.

Brand (NDA) 613%

Generic (ANDA) 4187%

Fluocinonide — 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.

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