BYDUREON BCise

AstraZeneca Pharmaceuticals LP🇺🇸 United States

FDA Page

Effective Date: May 4, 2023
Approval ID: 2d18cfc4-e0de-4814-a712-c1b7c504bff5
Products: 1 registered
Version: 32

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BYDUREON BCISE safely and effectively. See full prescribing information for BYDUREON BCISE. BYDUREON BCISE (exenatide) extended-release injectable suspension, for subcutaneous useInitial U.S. Approval: 2005

Quick Stats

Total Products1

Labelers2

Label Sections40

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.