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ACTIVE SUBSTANCE / INN

AVANAFIL

Brand name(s): AVANAFIL, Spedra, STENDRA
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NDA202276
ANDA209266
ACTIVE SUBSTANCE
Avanafil
REGULATORS
FDA · EMA
SPONSORS / MAH
Menarini International Operations Luxembourg S.A., HETERO LABS LTD V, VIVUS LLC
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AVANAFILANDA209266HETERO LABS LTD VPrescription
STENDRANDA202276VIVUS LLCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SpedraMenarini International Operations Luxembourg S.A.Authorised21/06/2013Erectile Dysfunction

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