Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-116 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018956s116,020608s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018956Orig1s116;020608Orig1s049ltr.pdf | |
| 02/18/2022 | SUPPL-113 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018956s113,020608s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018956Orig1s113; 020608Orig1s045ltr.pdf | |
| 08/05/2021 | SUPPL-112 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018956s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018956Orig1s112ltr.pdf | |
| 11/04/2020 | SUPPL-108 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956Orig1s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018956Orig1s108ltr.pdf | |
| 07/02/2020 | SUPPL-105 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018956Orig1s105ltr.pdf | |
| 04/17/2018 | SUPPL-101 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-116 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018956s116,020608s049lbl.pdf | |
| 02/18/2022 | SUPPL-113 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018956s113,020608s045lbl.pdf | |
| 08/05/2021 | SUPPL-112 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018956s112lbl.pdf | |
| 11/04/2020 | SUPPL-108 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956Orig1s108lbl.pdf | |
| 07/02/2020 | SUPPL-105 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956s105lbl.pdf | |
| 07/02/2020 | SUPPL-105 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956s105lbl.pdf | |
| 04/17/2018 | SUPPL-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf | |
| 04/17/2018 | SUPPL-101 | Labeling-Container/Carton Labels | 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 |