Application Nr Approved Date Route Status External Links
NDA205433 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Kitabis Pak (Co-Packaging Of Tobramycin Inhalation Solution And Pari Lc Plus Reusable Nebulizer) Is Indicated For The Management Of Cystic Fibrosis In Adults And Pediatric Patients 6 Years Of Age And Older With P. Aeruginosa . Safety And Efficacy Have Not Been Demonstrated In Patients Under The Age Of 6 Years, Patients With Fev 1 < 25% Or > 75% Predicted, Or Patients Colonized With Burkholderia Cepacia [See Clinical Studies ( 14 )]. Kitabis Pak Contains Tobramycin, An Aminoglycoside Antibacterial Drug Indicated For The Management Of Cystic Fibrosis In Adults And Pediatric Patients 6 Years Of Age And Older With Pseudomonas Aeruginosa ( 1 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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