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 | AP | 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 |
|---|---|---|---|---|---|
| 10/08/2024 | SUPPL-119 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018956Orig1s119,020608Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018956Orig1s119, 020608Orig1s047ltr.pdf | |
| 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-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.html |
| 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 |
|---|---|---|---|---|---|
| 10/08/2024 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018956Orig1s119,020608Orig1s047lbl.pdf | |
| 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-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 |
OMNIPAQUE 12
There are no Therapeutic Equivalents.
OMNIPAQUE 140
There are no Therapeutic Equivalents.
OMNIPAQUE 180
There are no Therapeutic Equivalents.
OMNIPAQUE 210
There are no Therapeutic Equivalents.
OMNIPAQUE 240
There are no Therapeutic Equivalents.
OMNIPAQUE 300
SOLUTION;INJECTION, ORAL, RECTAL; 64.7%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IOHEXOL | IOHEXOL | 64.7% | SOLUTION;INJECTION, ORAL, RECTAL | Prescription | No | AP | 217737 | AMNEAL |
| OMNIPAQUE 300 | IOHEXOL | 64.7% | SOLUTION;INJECTION, ORAL, RECTAL | Prescription | Yes | AP | 018956 | GE HEALTHCARE |
OMNIPAQUE 350
There are no Therapeutic Equivalents.
OMNIPAQUE 70
There are no Therapeutic Equivalents.
OMNIPAQUE 9
There are no Therapeutic Equivalents.