Application Nr Approved Date Route Status External Links
NDA201688 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tobi Podhaler Is Indicated For The Management Of Cystic Fibrosis Patients 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 >80% Predicted, Or Patients Colonized With Burkholderia Cepacia [See Clinical Studies (14) ] . Tobi Podhaler Is An Aminoglycoside Antibacterial Indicated For The Management Of Cystic Fibrosis Patients 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 >80%, Or Patients Colonized With Burkholderia Cepacia ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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