OCALIVA
NDA 207999 · New Drug Application (NDA) Discontinued
OBETICHOLIC ACID
- Sponsor (Drugs@FDA)
- INTERCEPT Company: INTERCEPT PHARMACEUTICALS, INC.
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | OCALIVA OBETICHOLIC ACID | TABLET;ORAL 5MG | Discontinued | AB | Reference listed drug | DISCNApproved |
| 002 | OCALIVA OBETICHOLIC ACID | TABLET;ORAL 10MG | Discontinued | AB | Reference listed drug | DISCNApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 8 | Approved | standard | Labeling | Letter for Supplement 8 (opens in a new tab)Label for Supplement 8 (opens in a new tab) | |
| Supplement 7 | Approved | standard | Labeling | Letter for Supplement 7 (opens in a new tab)Label for Supplement 7 (opens in a new tab) | |
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Supplement 1 | Approved | standard | Manufacturing (CMC) | None listed | |
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
14 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| RE48286Product 001 | Drug substance, Drug product | – | ||
| 10174073Product 001 | Drug substance | – | ||
| 9238673Product 001 | Drug product | – | ||
| 10047117Product 001 | Method of use | U-1854 | ||
| 10052337Product 001 | Drug product | – | ||
| 10751349Product 001 | Drug product | – | ||
| 10758549Product 001 | Method of use | U-2945 | ||
| RE48286Product 002 | Drug substance, Drug product | – | ||
| 9238673Product 002 | Drug product | – | ||
| 10174073Product 002 | Drug substance | – | ||
| 10047117Product 002 | Method of use | U-1854 | ||
| 10052337Product 002 | Drug product | – | ||
| 10751349Product 002 | Drug product | – | ||
| 10758549Product 002 | Method of use | U-2945 |
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
No NDC directory product carries this application number.
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.