Tacrolimus

Amneal Pharmaceuticals NY LLC🇺🇸 United States

FDA Page

Effective Date: Oct 20, 2025
Approval ID: 4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3
Products: 3 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TACROLIMUS EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TACROLIMUS EXTENDED-RELEASE CAPSULES. TACROLIMUS extended-release capsules, for oral use Initial U.S. Approval: 1994

Quick Stats

Total Products3

Labelers1

Label Sections18

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.