FDA Orange Book

Generic for Halog-e

Halog-e contains halcinonide. 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 Halog-e is halcinonide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Halog-e products in the Orange Book

Halog-e products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
cream, topical0.1%DiscontinuedNone2AB

NDA 018234, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic halcinonide

Approved generic versions of Halog-e
CompanyANDATE codeApprovedStrengths
MYLAN PHARMACEUTICALS INC211027AB (A-rated, therapeutically equivalent)August 12, 20190.1%
CHARTWELL RX SCIENCES LLC214723AB (A-rated, therapeutically equivalent)September 8, 20210.1%

Questions

Is there a generic for Halog-e?

Yes. The generic name for Halog-e is halcinonide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Halog-e?

The active ingredient in Halog-e is halcinonide, 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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