FDA Approves Primaquine Phosphate (NDA008316)

The U.S. Food and Drug Administration (FDA) has granted approval for Primaquine Phosphate (brand name PRIMAQUINE PHOSPHATE) under application number NDA008316. The product is an oral prescription tablet manufactured by Sanofi‑Aventis U.S. LLC and is classified as a human prescription drug. The drug’s submission history includes multiple manufacturing (CMC) and labeling submissions dating back to 1976, with the most recent labeling updates submitted in March 2025 (submission number 25). Earlier labeling revisions were recorded in 2008 (submission 17) and 2017 (submission 23). All listed submissions have an approval status (AP).