Tyblume

Exeltis USA, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 27, 2026
Approval ID: b2482d51-d606-4aaa-8af4-19e4fe2f8872
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TYBLUME safely and effectively. See full prescribing information for TYBLUME. TYBLUME (levonorgestrel and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1968 (norgestrel and ethinyl estradiol)

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.