Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020608
Company: GE HEALTHCARE
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 |
---|---|---|---|---|---|
04/25/2023 | SUPPL-49 | 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-45 | 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 | |
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 |
---|---|---|---|---|---|
04/25/2023 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018956s116,020608s049lbl.pdf | |
02/18/2022 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018956s113,020608s045lbl.pdf | |
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 |