Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020351
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISIPAQUE 270 IODIXANOL 55% INJECTABLE;INJECTION Prescription None Yes Yes
VISIPAQUE 320 IODIXANOL 65.2% INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/22/1996 ORIG-1 Approval Type 1 - New Molecular Entity 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-48 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-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf
04/05/2017 SUPPL-44 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020351Orig1s044.pdf
07/06/2015 SUPPL-43 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
11/20/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

09/12/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/05/2007 SUPPL-26 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/25/2005 SUPPL-21 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s021ltr.pdf
04/20/2005 SUPPL-20 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s020ltr.pdf
12/30/2004 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351s018ltr.pdf
03/24/2004 SUPPL-16 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351scp016ltr.pdf
12/18/2003 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20351slr013_visipaque_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351slr013ltr.pdf
09/04/2003 SUPPL-11 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351scp011ltr.pdf
12/03/2002 SUPPL-10 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20351scm010ltr.pdf
05/01/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/08/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1997 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

10/10/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/12/2019 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf
04/05/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s045lbl.pdf
04/05/2017 SUPPL-44 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s044lbl.pdf
07/06/2015 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf
12/18/2003 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20351slr013_visipaque_lbl.pdf

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