Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020316
Company: GUERBET

Products on NDA 20316

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXILAN-300	IOXILAN	62%	INJECTABLE;INJECTION	Discontinued	None	No	No
OXILAN-350	IOXILAN	73%	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 020316

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf
07/06/2015	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf