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ACTIVE SUBSTANCE / INN

OBETICHOLIC ACID

Brand name(s): Zektayos - Hepjuvo, OCALIVA, Ocaliva, OBETICHOLIC ACID
FDA LISTED
EMA LISTED
REVOKED
APPLICATION WITHDRAWN
DISCONTINUED
Fatty Liver
NDA207999
ACTIVE SUBSTANCE
Obeticholic Acid
REGULATORS
FDA · EMA
SPONSORS / MAH
INTERCEPT PHARMS INC, LUPIN LTD, Advanz Pharma Limited
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OBETICHOLIC ACIDANDA214980LUPIN LTDDiscontinued
OCALIVANDA207999INTERCEPT PHARMS INCDiscontinued
OBETICHOLIC ACIDANDA214935OPTIMUS PHARMA PRIVATE LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OcalivaAdvanz Pharma LimitedRevoked12/12/2016Liver Cirrhosis, Biliary
Zektayos - HepjuvoAdvanz Pharma LimitedApplication withdrawnFatty Liver

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