Catalyst Wire Dossier Catalyst Wire Dossier
FDA label_change · 2023-12-27

FDA Approved: PROMETHAZINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

View source ↗

Summary

FDA approved a supplemental application for Promethazine hydrochloride from Hikma Pharmaceuticals USA, authorizing changes to the product labeling under the AND…

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

Diseases / indications

Drugs mentioned

  • PROMETHAZINE HYDROCHLORIDE (Promethazine hydrochloride)

Snippet

SUPPL AP for PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE)