ACTIVE SUBSTANCE / INN

DARIFENACIN HYDROBROMIDE

Brand name(s): Emselex, ENABLEX, DARIFENACIN HYDROBROMIDE, DARIFENACIN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA206743
ANDA207302
ACTIVE SUBSTANCE
Darifenacin Hydrobromide
REGULATORS
FDA · EMA
SPONSORS / MAH
ABBVIE, AUROBINDO PHARMA, JUBILANT GENERICS
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ENABLEXNDA021513ABBVIEDiscontinued
DARIFENACIN HYDROBROMIDEANDA205550JUBILANT GENERICSDiscontinued
DARIFENACIN HYDROBROMIDEANDA206743AUROBINDO PHARMAPrescription
DARIFENACINANDA207302MACLEODS PHARMS LTDPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Emselexpharmaand GmbHAuthorised22/10/2004Urinary Incontinence, Urge;Urinary Bladder, Overactive

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