Transmucosal Fentanyl Citrate

H.J. Harkins Company, Inc.🇺🇸 United States

FDA Page

Effective Date: Sep 6, 2011
Approval ID: e4ce209d-3f8c-4ac4-bec1-2525a93708bc
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 Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968

Quick Stats

Total Products3

Labelers2

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.