FDA Orange Book

Generic for Lidex-e

Lidex-e contains fluocinonide. 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 Lidex-e is fluocinonide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.

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Lidex-e products in the Orange Book

Lidex-e products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical0.05%DiscontinuedNone10AB1, AB2

NDA 016908, held by ALVOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic fluocinonide

Approved generic versions of Lidex-e
CompanyANDATE codeApprovedStrengths
SUN PHARMA CANADA INC071500AB1 (A-rated, therapeutically equivalent)June 10, 19870.05%
TARO PHARMACEUTICAL INDUSTRIES LTD072494AB2 (A-rated, therapeutically equivalent)January 19, 19890.05%
TEVA PHARMACEUTICALS USA INC072488AB1 (A-rated, therapeutically equivalent)February 6, 19890.05%
TEVA PHARMACEUTICALS USA INC072490AB2 (A-rated, therapeutically equivalent)February 7, 19890.05%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC073085AB1 (A-rated, therapeutically equivalent)February 14, 19920.05%
FOUGERA PHARMACEUTICALS INC073030AB1 (A-rated, therapeutically equivalent)October 17, 19940.05%
COSETTE PHARMACEUTICALS NC LABORATORIES LLC074204AB2 (A-rated, therapeutically equivalent)June 13, 19950.05%
FOUGERA PHARMACEUTICALS INC076586AB2 (A-rated, therapeutically equivalent)June 23, 20040.05%
AMNEAL PHARMACEUTICALS LLC210554AB1 (A-rated, therapeutically equivalent)August 21, 20180.05%
ENCUBE ETHICALS PRIVATE LTD211410AB1 (A-rated, therapeutically equivalent)October 16, 20180.05%

Questions

Is there a generic for Lidex-e?

Yes. The generic name for Lidex-e is fluocinonide. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.

What is the generic name for Lidex-e?

The active ingredient in Lidex-e is fluocinonide, 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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