FDA Orange Book

Generic for Eulexin

Eulexin contains flutamide. 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 Eulexin is flutamide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

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Eulexin products in the Orange Book

Eulexin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral125MGDiscontinuedNone1None

NDA 018554, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic flutamide

Approved generic versions of Eulexin
CompanyANDATE codeApprovedStrengths
WAYLIS THERAPEUTICS LLC075298None (No TE code listed)September 18, 2001125MG

Questions

Is there a generic for Eulexin?

Yes. The generic name for Eulexin is flutamide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.

What is the generic name for Eulexin?

The active ingredient in Eulexin is flutamide, 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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