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ACTIVE SUBSTANCE / INN

TOBRAMYCIN

Brand name(s): Vantobra, TOBRAMYCIN AND DEXAMETHASONE, Vantobra (previously Tobramycin PARI), TOBI, TOBRADEX ST, BETHKIS, TOBRAMYCIN, AKTOB, TOBRASONE, ZYLET, Tobi Podhaler, TOBREX
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
ANDA207444
NDA050541
ACTIVE SUBSTANCE
Tobramycin
REGULATORS
FDA · EMA
SPONSORS / MAH
EPIC PHARMA LLC, BAUSCH AND LOMB, VIATRIS
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TOBRAMYCINANDA207444SOMERSET THERAPS LLCPrescription
TOBINDA050753VIATRISPrescription
ZYLETNDA050804BAUSCH AND LOMBPrescription
TOBRAMYCIN AND DEXAMETHASONEANDA212715PADAGIS USPrescription
TOBRADEX STNDA050818HARROW EYEPrescription
BETHKISNDA201820CHIESIPrescription
TOBRAMYCINANDA209554PHARMOBEDIENTDiscontinued
TOBREXNDA050541NOVARTISDiscontinued
TOBRASONENDA050628HARROW EYEDiscontinued
AKTOBANDA064096EPIC PHARMA LLCDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Tobi PodhalerViatris Healthcare LimitedAuthorised20/07/2011Cystic Fibrosis;Respiratory Tract Infections
Vantobra (previously Tobramycin PARI)Pari Pharma GmbHAuthorised18/02/2019Respiratory Tract Infections;Cystic Fibrosis
VantobraPari Pharma GmbHWithdrawn18/03/2015Cystic Fibrosis;Respiratory Tract Infections

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