Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021425
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ULTRAVIST (PHARMACY BULK) | IOPROMIDE | 62.3% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| ULTRAVIST (PHARMACY BULK) | IOPROMIDE | 76.9% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| ULTRAVIST (PHARMACY BULK) | IOPROMIDE | 49.9% | INJECTABLE;INJECTION | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/20/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21425ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021425_ultravist.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2023 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021425s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020220Orig1s056;021425Orig1s038ltr.pdf | |
| 06/15/2023 | SUPPL-37 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220Orig1s055;021425Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020220Orig1s055;021425Orig1s037ltr.pdf | |
| 05/25/2023 | SUPPL-36 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220s054,021425s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020220Orig1s054;021425Orig1s036ltr.pdf | |
| 02/18/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020220s052,021425s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020220Orig1s052; 021425Orig1s034ltr.pdf | |
| 08/01/2019 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021425s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021425Orig1s030, 020220Orig1s047ltr.pdf | |
| 05/04/2018 | SUPPL-29 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021425Orig1s029ltr.pdf |
| 04/02/2018 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021425s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021425s028ltr.pdf | |
| 04/05/2017 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021425s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020220Orig1s042,021425Orig1s026ltr.pdf | |
| 11/17/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020220Orig1s041,021425Orig1s024ltr.pdf | |
| 05/02/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf | |
| 11/13/2009 | SUPPL-19 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf |
| 06/23/2010 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021425s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021425s017ltr.pdf | |
| 08/31/2007 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021425s012ltr.pdf | |
| 03/12/2004 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21425scp006_ultravist_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21425scp006ltr.pdf | |
| 01/23/2003 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21425slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-37 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220Orig1s055;021425Orig1s037lbl.pdf | |
| 06/15/2023 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220Orig1s055;021425Orig1s037lbl.pdf | |
| 05/25/2023 | SUPPL-36 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220s054,021425s036lbl.pdf | |
| 04/25/2023 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021425s038lbl.pdf | |
| 02/18/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020220s052,021425s034lbl.pdf | |
| 08/01/2019 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021425s030lbl.pdf | |
| 04/02/2018 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021425s028lbl.pdf | |
| 04/05/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021425s026lbl.pdf | |
| 07/06/2015 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf | |
| 05/02/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021425s020lbl.pdf | |
| 06/23/2010 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021425s017lbl.pdf | |
| 08/31/2007 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021425s012lbl.pdf | |
| 03/12/2004 | SUPPL-6 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21425scp006_ultravist_lbl.pdf | |
| 09/20/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21425lbl.pdf |