Ocaliva

NDA 207999, held by Intercept. Obeticholic Acid.

As of Nov 14, 2026, NDA 207999 (Ocaliva), held by Intercept, was first approved by FDA on May 27, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: May 27, 2016
Review: Priority
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 27, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Ocaliva5MG · tablet;oral	Obeticholic Acid	DiscontinuedReference drug
Ocaliva10MG · tablet;oral	Obeticholic Acid	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Feb 24, 2022	Supplement 8Labeling · Standard review	Approved	Letter Label
May 26, 2021	Supplement 7Labeling · Standard review	Approved	Label Medication Guide Letter Letter
Feb 1, 2018	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 21, 2016	Supplement 1Manufacturing · Standard review	Approved	None posted
May 27, 2016	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 207999
Drugs@FDA: Overview at FDA
Company: Intercept Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters