FDA Orange Book
Generic for Ctexli
Ctexli 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 Ctexli is chenodiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Ctexli products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | None | 1 | None |
NDA 219488, held by MIRUM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic chenodiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LGM PHARMA SOLUTIONS LLC | 091019 | None (No TE code listed) | October 22, 2009 | 250MG |
Ctexli exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | February 21, 2028 | 219488 |
| ODE-523 | Orphan drug exclusivity | February 21, 2032 | 219488 |
Ctexli NDC codes
Questions
Is there a generic for Ctexli?
Yes. The generic name for Ctexli is chenodiol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Ctexli?
The active ingredient in Ctexli 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.