Catalyst Wire Dossier Catalyst Wire Dossier
FDA label_change · 2015-11-12

FDA Approved: MIRALAX — Supplemental Application (Bayer HealthCare LLC.)

View source ↗

Summary

FDA approved a supplemental application for Miralax (polyethylene glycol 3350) filed by Bayer HealthCare LLC. The action updates the labeling under NDA 022015.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • MIRALAX (POLYETHYLENE GLYCOL 3350)

Snippet

SUPPL AP for MIRALAX (POLYETHYLENE GLYCOL 3350)