GOPRELTO

Genus Lifesciences Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 8, 2023
Approval ID: 689750b7-8e51-47d9-a428-078f3f6c9dec
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GOPRELTO safely and effectively. See full prescribing information for GOPRELTO. GOPRELTO (cocaine hydrochloride) nasal solution, for intranasal use, CII Initial U.S. Approval: 2017

Quick Stats

Total Products1

Labelers2

Label Sections27

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.