Omnitrope

Sandoz Inc🇺🇸 United States

FDA Page

Effective Date: Jul 10, 2025
Approval ID: 58d84ffa-4056-4e36-ad67-7bd4aef444a5
Products: 3 registered
Version: 36

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OMNITROPE safely and effectively. See full prescribing information for OMNITROPE.OMNITROPE (somatropin) injection, for subcutaneous useOMNITROPE (somatropin) for injection, for subcutaneous useInitial U.S. Approval: 1987

Quick Stats

Total Products3

Labelers2

Label Sections19

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.