Application Nr Approved Date Route Status External Links
NDA050753 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tobi Is Indicated For The Management Of Cystic Fibrosis In Adults And Pediatric Patients 6 Years Of Age And Older With Pseudomonas Aeruginosa . Safety And Efficacy Have Not Been Demonstrated In Patients Under The Age Of 6 Years, Patients With Forced Expiratory Volume In 1 Second (Fev 1 ) < 25% Or > 75% Predicted, Or Patients Colonized With Burkholderia Cepacia [See Clinical Studies (14) ]. Tobi Is An Aminoglycoside Antibacterial Indicated For The Management Of Cystic Fibrosis In Adults And Pediatric Patients 6 Years Of Age And Older With Pseudomonas Aeruginosa . Safety And Efficacy Have Not Been Demonstrated In Patients Under The Age Of 6 Years, Patients With Forced Expiratory Volume In 1 Second (Fev 1 ) < 25% Or > 75% Predicted, Or Patients Colonized With Burkholderia Cepacia .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tobramycin TOBRAMYCIN ZINC8214692

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