Hydrocodone Bitartrate and Homatropine Methylbromide

KVK-Tech, Inc.🇺🇸 United States

FDA Page

Effective Date: May 22, 2026
Approval ID: 9a737416-08e0-4df6-897e-cf9d1b5f0b01
Products: 1 registered
Version: 13

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 1943

Quick Stats

Total Products1

Labelers2

Label Sections18

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.