Is there a generic for Amcinonide?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Amcinonide, referencing the brand CYCLOCORT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amcinonide?

CYCLOCORT (NDA 019729, ASTELLAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amcinonide are approved?

Amcinonide is approved in the following dosage forms: cream, lotion, ointment.

FDA Orange Book · active-ingredient family

Amcinonide

Amcinonide: 3 brands, 5 generics; first approved Jun 13, 1988; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 5 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CYCLOCORTRLD

ASTELLASNDA 0197291988

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

CYCLOCORTRLD

ASTELLASNDA 018116—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM	TOPICAL	Discontinued	—
0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM	TOPICAL	Discontinued	—

CYCLOCORTRLD

ASTELLASNDA 018498—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT	TOPICAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (5)

AMCINONIDERS

GENUS LIFESCIENCESANDA 0760652003

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

AMCINONIDE

TARO PHARM INDSANDA 0763672003

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

AMCINONIDERS

GENUSANDA 0760962002

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

AMCINONIDERS

SOLUBIOMIXANDA 0763292002

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

AMCINONIDE

TARO PHARM INDSANDA 0762292002

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

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

Jun 13, 1988

38 yr 8 mo ago

Most recent approval

May 15, 2003

23 yr 6 mo ago

Approvals span 1988–2003 across 8 FDA applications.

Brand (NDA) 338%

Generic (ANDA) 563%

Amcinonide — 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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