TOBI Podhaler

Mylan Specialty L.P.🇺🇸 United States

FDA Page

Effective Date: Apr 15, 2026
Approval ID: c4b5bb1f-e158-4ac1-9c35-e98a416c743a
Products: 1 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TOBI PODHALER safely and effectively. See full prescribing information for TOBI PODHALER. TOBI PODHALER (tobramycin inhalation powder), for oral inhalation useInitial U.S. Approval: 1975

Quick Stats

Total Products1

Labelers2

Label Sections20

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.