Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018905
Company: GUERBET

Products on NDA 18905

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEXABRIX	IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM	39.3%;19.6%	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 018905

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018905s025lbl.pdf
07/06/2015	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018905s024lbl.pdf