Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020808
Company: GE HEALTHCARE
Company: GE HEALTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VISIPAQUE 270 | IODIXANOL | 55% | INJECTABLE;INJECTION | Discontinued | None | No | No |
VISIPAQUE 320 | IODIXANOL | 65.2% | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
08/29/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020351s057,020808s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020351Orig1s057;020808Orig1s035ltr.pdf | |
02/18/2022 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020351s054,020808s032lbl.pdf | |
03/12/2019 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020351Orig1s048, 020808Orig1s028ltr.pdf | |
04/05/2017 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf | |
04/05/2017 | SUPPL-25 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020808Orig1s025.pdf | |
07/06/2015 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020351Orig1s043,020808Orig1s024ltr.pdf | |
01/18/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/18/2003 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808slr004ltr.pdf | |
09/04/2003 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20808scp002ltr.pdf |
01/28/1999 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20808-S1_Visipaque.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/25/2023 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020351s057,020808s035lbl.pdf | |
02/18/2022 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020351s054,020808s032lbl.pdf | |
03/12/2019 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf | |
04/05/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s026lbl.pdf | |
04/05/2017 | SUPPL-25 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020808s025lbl.pdf | |
07/06/2015 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf | |
12/18/2003 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20808slr004_visipaque_lbl.pdf |