Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Status
Approved
Full Title
These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS, USP.ROSUVASTATIN TABLETS, USP, for oral use Initial U.S. Approval: 2003 ------------- RECENT MAJOR CHANGES ---------- Contraindications, Pregnancy and Lactation (4) Removed 01/2023 Warnings and Precautions (5.2) 01/2023 Warnings and Precautions, Concomitant Coumarin Anticoagulants (5.4) Removed 01/2023
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.
