Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020351
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 | Prescription | AP | Yes | Yes |
| VISIPAQUE 320 | IODIXANOL | 65.2% | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 03/22/1996 | 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-57 | 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-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020351s054,020808s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020351Orig1s054; 020808Orig1s032ltr.pdf | |
| 05/08/2020 | SUPPL-52 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020351Orig1s052ltr.pdf |
| 07/02/2020 | SUPPL-50 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020351s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020351Orig1s050ltr.pdf | |
| 03/12/2019 | SUPPL-48 | 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-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s045,020808Orig1s026ltr.pdf | |
| 04/05/2017 | SUPPL-44 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020351Orig1s0044,020808Orig1s0025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/020351Orig1s044.pdf | |
| 07/06/2015 | SUPPL-43 | 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 | |
| 11/20/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/2007 | SUPPL-26 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2005 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s021ltr.pdf |
| 04/20/2005 | SUPPL-20 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020351s020ltr.pdf |
| 12/30/2004 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351s018ltr.pdf |
| 03/24/2004 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20351scp016ltr.pdf |
| 12/18/2003 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20351slr013_visipaque_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351slr013ltr.pdf | |
| 09/04/2003 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20351scp011ltr.pdf |
| 12/03/2002 | SUPPL-10 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20351scm010ltr.pdf |
| 05/01/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/10/1997 | 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-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020351s057,020808s035lbl.pdf | |
| 02/18/2022 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020351s054,020808s032lbl.pdf | |
| 07/02/2020 | SUPPL-50 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020351s050lbl.pdf | |
| 07/02/2020 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020351s050lbl.pdf | |
| 03/12/2019 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020351s048,020808s028lbl.pdf | |
| 04/05/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s045lbl.pdf | |
| 04/05/2017 | SUPPL-44 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020351s044lbl.pdf | |
| 07/06/2015 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020351s043,020808s024lbl.pdf | |
| 12/18/2003 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20351slr013_visipaque_lbl.pdf |
VISIPAQUE 270
INJECTABLE;INJECTION; 55%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IODIXANOL | IODIXANOL | 55% | INJECTABLE;INJECTION | Prescription | No | AP | 214271 | HENGRUI PHARMA |
| VISIPAQUE 270 | IODIXANOL | 55% | INJECTABLE;INJECTION | Prescription | Yes | AP | 020351 | GE HEALTHCARE |
VISIPAQUE 320
INJECTABLE;INJECTION; 65.2%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| IODIXANOL | IODIXANOL | 65.2% | INJECTABLE;INJECTION | Prescription | No | AP | 214271 | HENGRUI PHARMA |
| VISIPAQUE 320 | IODIXANOL | 65.2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 020351 | GE HEALTHCARE |