Pramipexole Dihydrochloride

Torrent Pharmaceuticals Limited🇺🇸 United States

FDA Page

Effective Date: Mar 31, 2026
Approval ID: 60167d7c-469f-455a-a113-561841af5e59
Products: 6 registered
Version: 22

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PRAMIPEXOLE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PRAMIPEXOLE DIHYDROCHLORIDE TABLETS. PRAMIPEXOLE DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

Quick Stats

Total Products6

Labelers2

Label Sections36

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.