Spravato

Janssen Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Mar 31, 2026
Approval ID: d81a6a79-a74a-44b7-822c-0dfa3036eaed
Products: 1 registered
Version: 20

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use SPRAVATO safely and effectively. See full prescribing information for SPRAVATO. SPRAVATO (esketamine) nasal spray, CIII Initial U.S. Approval: 1970 (ketamine)

Quick Stats

Total Products1

Labelers2

Label Sections45

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.