Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020808
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISIPAQUE 270 IODIXANOL 55% INJECTABLE;INJECTION Discontinued None No No
VISIPAQUE 320 IODIXANOL 65.2% INJECTABLE;INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/12/2019 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020351Orig1s048, 020808Orig1s028ltr.pdf
04/05/2017 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf
04/05/2017 SUPPL-25 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020808Orig1s025.pdf
07/06/2015 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf
01/18/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/18/2003 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808slr004ltr.pdf
09/04/2003 SUPPL-2 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808scp002ltr.pdf
01/28/1999 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20808-S1_Visipaque.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/12/2019 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf
04/05/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf
04/05/2017 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf
07/06/2015 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf
12/18/2003 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf

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