Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018956
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNIPAQUE 12 IOHEXOL 2.6% SOLUTION;ORAL Prescription None Yes Yes
OMNIPAQUE 140 IOHEXOL 30.2% INJECTABLE;INJECTION Prescription None Yes Yes
OMNIPAQUE 180 IOHEXOL 38.8% SOLUTION;INJECTION, ORAL, RECTAL Prescription None Yes Yes
OMNIPAQUE 210 IOHEXOL 45.3% INJECTABLE;INJECTION Discontinued None No No
OMNIPAQUE 240 IOHEXOL 51.8% SOLUTION;INJECTION, ORAL, RECTAL Prescription None Yes Yes
OMNIPAQUE 300 IOHEXOL 64.7% SOLUTION;INJECTION, ORAL, RECTAL Prescription None Yes Yes
OMNIPAQUE 350 IOHEXOL 75.5% SOLUTION;INJECTION, ORAL Prescription None Yes Yes
OMNIPAQUE 70 IOHEXOL 15.1% SOLUTION;URETHRAL Discontinued None No No
OMNIPAQUE 9 IOHEXOL 1.9% SOLUTION;ORAL 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
12/26/1985 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
04/17/2018 SUPPL-101 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018956Orig1s101ltr.pdf
04/05/2017 SUPPL-99 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018956s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018956Orig1s099,020608s036s037ltr.pdf
10/21/2015 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

07/06/2015 SUPPL-95 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
03/03/2015 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

06/19/2014 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

11/20/2013 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

02/10/2014 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

08/21/2013 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

10/01/2007 SUPPL-76 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018956s076ltr.pdf
03/25/2005 SUPPL-65 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18956s065ltr.pdf
12/27/2004 SUPPL-62 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956s062ltr.pdf
03/05/2004 SUPPL-58 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18956slr058ltr.pdf
11/20/2002 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

08/05/2002 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

12/19/2000 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1998 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/2002 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr049ltr.pdf
08/18/1995 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/04/1994 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/18/1995 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/15/1995 SUPPL-43 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18956a_s043_061595.pdf
11/28/1995 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1994 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/20/1992 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/2002 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18956slr039ltr.pdf
09/30/1992 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/11/1992 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/01/1994 SUPPL-36 Labeling

Label is not available on this site.

06/01/1994 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1993 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1993 SUPPL-33 Labeling

Label is not available on this site.

03/01/1993 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1993 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/04/1995 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1990 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/13/1993 SUPPL-28 Efficacy-New Route Of Administration Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018956-S28_Omnipaque_toc.cfm
03/26/1992 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1989 SUPPL-26 Efficacy-New Patient Population

Label is not available on this site.

05/03/1989 SUPPL-24 Labeling

Label is not available on this site.

07/28/1989 SUPPL-23 Efficacy-New Indication

Label is not available on this site.

07/28/1989 SUPPL-22 Efficacy-New Patient Population

Label is not available on this site.

06/30/1989 SUPPL-21 Efficacy-New Indication

Label is not available on this site.

06/30/1989 SUPPL-20 Efficacy-New Indication

Label is not available on this site.

01/04/1989 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1989 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

11/30/1988 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

04/18/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/24/1988 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

07/29/1988 SUPPL-14 Efficacy-New Indication

Label is not available on this site.

01/27/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1988 SUPPL-12 Efficacy-New Patient Population

Label is not available on this site.

05/22/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/12/1987 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

12/23/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/04/1987 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/27/1987 SUPPL-6 Labeling

Label is not available on this site.

04/21/1987 SUPPL-4 Labeling

Label is not available on this site.

11/20/1986 SUPPL-3 Labeling

Label is not available on this site.

02/05/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/26/1986 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2018 SUPPL-101 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf
04/17/2018 SUPPL-101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf
04/05/2017 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018956s099lbl.pdf
07/06/2015 SUPPL-95 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf

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