Orange Book product · Brand (NDA)
CTEXLI
CHENODIOL
At a glance
Feb 21, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 21, 2025
1 yr 4 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
Exclusivity ends · ODE-523
Orphan-drug exclusivity (7 years)
Feb 21, 2032
in 5 yr 9 mo
Pharmaceutical detail
Active ingredient
CHENODIOL
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219488
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
- ODE-523Orphan-drug exclusivity (7 years)
Feb 21, 2032
in 5 yr 9 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
