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ACTIVE SUBSTANCE / INN

SILODOSIN

Brand name(s): Silodyx, Silodosin Recordati, RAPAFLO, SILODOSIN, Urorec
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA022206
ANDA210396
ACTIVE SUBSTANCE
Silodosin
REGULATORS
FDA · EMA
SPONSORS / MAH
Recordati Ireland Ltd, CHARTWELL RX, TORRENT
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SILODOSINANDA204726CHARTWELL RXPrescription
SILODOSINANDA210396TORRENTDiscontinued
RAPAFLONDA022206ABBVIEDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
UrorecRecordati Ireland LtdAuthorised29/01/2010Prostatic Hyperplasia
SilodyxRecordati Ireland LtdAuthorised29/01/2010Prostatic Hyperplasia
Silodosin RecordatiRecordati Ireland LtdAuthorised07/01/2019Prostatic Hyperplasia

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