U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 009190
Company: GUERBET

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIPIODOL ETHIODIZED OIL EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML) OIL;INTRALYMPHATIC, INTRAUTERINE Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/05/2023 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009190s032lbl.pdf
06/10/2020 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf
06/10/2020 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf
04/04/2014 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf
03/21/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf
Back to Top