ACTIVE SUBSTANCE / INN

METHYLNALTREXONE BROMIDE

Brand name(s): RELISTOR, METHYLNALTREXONE BROMIDE, Relistor
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA208271
ANDA208038
ACTIVE SUBSTANCE
Methylnaltrexone Bromide
REGULATORS
FDA · EMA
SPONSORS / MAH
Bausch Health Ireland Limited, SALIX, ACTAVIS LLC
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
METHYLNALTREXONE BROMIDEANDA208038US GENERICS, STERILESNone (Tentative Approval)
METHYLNALTREXONE BROMIDEANDA208112ACTAVIS LLCDiscontinued
RELISTORNDA208271SALIXPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RelistorBausch Health Ireland LimitedAuthorised01/07/2008Opioid-Related Disorders;Constipation

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