FDA Orange Book · active-ingredient family
Chenodiol
Chenodiol is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CTEXLI · NDA 219488
2
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · tablet
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHENODIOL | LGM PHARMA | ANDA 091019 | — | Oct 22, 2009 |
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.
Chenodiol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
