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ACTIVE SUBSTANCE / INN

TADALAFIL

Brand name(s): ENTADFI, CIALIS, TADALAFIL, TADLIQ, Cialis, Tadalafil Lilly, Talmanco (previously Tadalafil Generics), Tadalafil Mylan, ALYQ, Adcirca (previously Tadalafil Lilly), FINASTERIDE AND TADALAFIL, OPSYNVI
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA200630
ANDA090141
ACTIVE SUBSTANCE
Tadalafil
REGULATORS
FDA · EMA
SPONSORS / MAH
ZYDUS LIFESCIENCES, PHARMOBEDIENT, CMP DEV LLC
TOTAL APPLICATIONS
15
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TADALAFILANDA090141TEVA PHARMS USAPrescription
TADALAFILANDA200630PHARMOBEDIENTDiscontinued
TADLIQNDA214522CMP DEV LLCPrescription
ALYQANDA209942TEVA PHARMS USAPrescription
OPSYNVINDA218490ACTELIONPrescription
CIALISNDA021368LILLYPrescription
CIALISNDA021368LILLYDiscontinued
ENTADFINDA215423BLUE WATER BIOTECHDiscontinued
FINASTERIDE AND TADALAFILANDA218232ZYDUS LIFESCIENCESDiscontinued
FINASTERIDE AND TADALAFILANDA218499NOVITIUM PHARMAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Tadalafil MylanMylan Pharmaceuticals LimitedAuthorised21/11/2014Erectile Dysfunction
Tadalafil LillyEli Lilly Nederland B.V.Authorised22/03/2017Erectile Dysfunction
CialisEli Lilly Nederland B.V.Authorised12/11/2002Erectile Dysfunction
Adcirca (previously Tadalafil Lilly)Eli Lilly Nederland B.V.Authorised01/10/2008Hypertension, Pulmonary
Talmanco (previously Tadalafil Generics)Viatris LimitedAuthorised09/01/2017Hypertension, Pulmonary

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