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ACTIVE SUBSTANCE / INN

ELUXADOLINE

Brand name(s): Truberzi, ELUXADOLINE, VIBERZI
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
NDA206940
ANDA213522
ACTIVE SUBSTANCE
Eluxadoline
REGULATORS
FDA · EMA
SPONSORS / MAH
Allergan Pharmaceuticals International Limited, ABBVIE, MSN PHARMACEUTICALS INC
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ELUXADOLINEANDA213522ZYDUS PHARMSDiscontinued
ELUXADOLINEANDA213613ASCEND LABORATORIES, LTDPrescription
VIBERZINDA206940ABBVIEPrescription
ELUXADOLINEANDA213576MSN PHARMACEUTICALS INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
TruberziAllergan Pharmaceuticals International LimitedWithdrawn19/09/2016Irritable Bowel Syndrome;Diarrhea

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