dabigatran etexilate

Apotex Corp.🇺🇸 United States

FDA Page

Effective Date: Feb 13, 2024
Approval ID: dd47a015-ff90-d7a7-8dcb-4e6e31a68071
Products: 0 registered
Version: 1

Regulatory Information

Labeling Type

34391-3

Status

Approved

Full Title

{"content": [{"@styleCode": "bold", "#text": "These highlights do not include all the information needed to use DABIGATRAN"}, {"@styleCode": "bold", "#text": "ETEXILATE CAPSULES"}, {"@styleCode": "bold", "#text": "safely and effectively. See full prescribing information for"}, {"@styleCode": "bold", "#text": "DABIGATRAN"}, {"@styleCode": "bold", "#text": "ETEXILATE CAPSULES."}, {"@styleCode": "bold", "#text": "DABIGATRAN E"}, {"@styleCode": "bold", "#text": "TEXILATE capsules, for oral use"}, {"@styleCode": "bold", "#text": "Initial U.S. Approval: 2010"}], "br": [null, null, null]}

Quick Stats

Total Products0

Labelers1

Label Sections23

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.