Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020608
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNIPAQUE 240 IOHEXOL 51.8% SOLUTION;INJECTION, ORAL, RECTAL Discontinued None No No
OMNIPAQUE 300 IOHEXOL 64.7% SOLUTION;INJECTION, ORAL, RECTAL Prescription None No No
OMNIPAQUE 350 IOHEXOL 75.5% SOLUTION;INJECTION, ORAL 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
10/24/1995 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/09/2017 SUPPL-38 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020608Orig1s038ltr.pdf
04/05/2017 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018956Orig1s099,020608s036s037ltr.pdf
04/05/2017 SUPPL-36 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s036lbl.pdf
12/21/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020608s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020608Orig1s034ltr.pdf
07/06/2015 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018956Orig1s095,020608Orig1s031ltr.pdf
10/01/2007 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020608s018ltr.pdf
02/13/2004 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20608slr010ltr.pdf
03/05/2004 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20608slr009ltr.pdf
11/20/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/05/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/19/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/04/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/10/1998 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
11/09/2017 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf
11/09/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s038lbl.pdf
04/05/2017 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s037lbl.pdf
04/05/2017 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020608s036lbl.pdf
12/21/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020608s034lbl.pdf
07/06/2015 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf

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