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FDA NDA · NDA207999

OCALIVA

Sponsor: INTERCEPT

APPLICATION
NDA207999
TYPE
NDA
ORIGINAL APPROVAL
2016-05-27
LATEST ACTION
2022-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OCALIVA · ReferenceDiscontinued
OBETICHOLIC ACID 10MG · TABLET · ORAL
OCALIVA · ReferenceDiscontinued
OBETICHOLIC ACID 5MG · TABLET · ORAL

Approval history

2022-02-24Labeling · Supplement 8 · standard — Letter ↗AP
2021-05-26Labeling · Supplement 7 · standard — Letter ↗AP
2018-02-01Labeling · Supplement 3 · standard — Label ↗AP
2016-12-21Manufacturing (CMC) · Supplement 1 · standardAP
2016-05-27Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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