FDA Orange Book

Generic for Cyclocort

Cyclocort contains amcinonide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Cyclocort is amcinonide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 3 of the 4 Cyclocort products the Orange Book lists.

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Cyclocort products in the Orange Book

Cyclocort products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical0.025%DiscontinuedNone0None
cream, topical0.1%DiscontinuedNone1None
lotion, topical0.1%DiscontinuedNone1None
ointment, topical0.1%DiscontinuedNone1None

NDA 018116, 019729, 018498, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic amcinonide

Approved generic versions of Cyclocort
CompanyANDATE codeApprovedStrengths
TARO PHARMACEUTICAL INDUSTRIES LTD076229None (No TE code listed)May 31, 20020.1%
SOLUBIOMIX LLC076329None (No TE code listed)November 6, 20020.1%
GENUS LIFESCIENCES INC076096None (No TE code listed)November 19, 20020.1%

Questions

Is there a generic for Cyclocort?

Yes. The generic name for Cyclocort is amcinonide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 3 of the 4 Cyclocort products the Orange Book lists.

What is the generic name for Cyclocort?

The active ingredient in Cyclocort is amcinonide, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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