EPIPEN

Mylan Specialty L.P.🇺🇸 United States

FDA Page

Effective Date: Feb 15, 2023
Approval ID: 7560c201-9246-487c-a13b-6295db04274a
Products: 2 registered
Version: 35

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use EPIPEN and EPIPEN Jr safely and effectively. See full prescribing information for EPIPEN and EPIPEN Jr. EPIPEN (epinephrine injection), for intramuscular or subcutaneous useEPIPEN Jr (epinephrine injection), for intramuscular or subcutaneous useInitial U.S. Approval: 1939

Quick Stats

Total Products2

Labelers2

Label Sections17

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.