FDA Orange Book

Generic for Chenix

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

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Chenix products in the Orange Book

Chenix products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral250MGDiscontinuedNone1None

NDA 018513, held by LEADIANT BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic chenodiol

Approved generic versions of Chenix
CompanyANDATE codeApprovedStrengths
LGM PHARMA SOLUTIONS LLC091019None (No TE code listed)October 22, 2009250MG

Questions

Is there a generic for Chenix?

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

What is the generic name for Chenix?

The active ingredient in Chenix is chenodiol, 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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