Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020220
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ULTRAVIST 150 | IOPROMIDE | 31.2% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ULTRAVIST 240 | IOPROMIDE | 49.9% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ULTRAVIST 300 | IOPROMIDE | 62.3% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| ULTRAVIST 300 IN PLASTIC CONTAINER | IOPROMIDE | 62.3% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ULTRAVIST 370 | IOPROMIDE | 76.9% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/1995 | 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-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020220Orig1s056;021425Orig1s038ltr.pdf | |
| 06/15/2023 | SUPPL-55 | 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-54 | 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-52 | 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-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020220s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021425Orig1s030, 020220Orig1s047ltr.pdf | |
| 04/24/2018 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020220Orig1s046ltr.pdf | |
| 04/02/2018 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020220s045ltr.pdf | |
| 07/27/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020220Orig1s043ltr.pdf | |
| 04/05/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Label (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220Orig1s042,021425Orig1s026ltr.pdf | |
| 07/06/2015 | SUPPL-41 | 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 | |
| 07/29/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2012 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020220s036ltr.pdf | |
| 11/13/2009 | SUPPL-35 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf |
| 12/30/2009 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s033,021425s017ltr.pdf | |
| 08/31/2007 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020220s027ltr.pdf | |
| 08/12/2005 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020220s022ltr.pdf |
| 03/12/2004 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20220scp018_ultravist_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20220scp018ltr.pdf | |
| 10/30/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/24/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/2003 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20220slr008ltr.pdf |
| 12/27/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1997 | SUPPL-2 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 05/30/1995 | 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 |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-55 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220Orig1s055;021425Orig1s037lbl.pdf | |
| 06/15/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220Orig1s055;021425Orig1s037lbl.pdf | |
| 05/25/2023 | SUPPL-54 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220s054,021425s036lbl.pdf | |
| 04/25/2023 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020220s056lbl.pdf | |
| 02/18/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020220s052,021425s034lbl.pdf | |
| 08/01/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020220s047lbl.pdf | |
| 04/24/2018 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s046lbl.pdf | |
| 04/02/2018 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020220s045lbl.pdf | |
| 07/27/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s043lbl.pdf | |
| 04/05/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220s042lbl.pdf | |
| 04/05/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020220Orig1s042,021425Orig1s026ltr.pdf | |
| 07/06/2015 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf | |
| 05/02/2012 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf | |
| 12/30/2009 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf | |
| 08/31/2007 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020220s027lbl.pdf | |
| 03/12/2004 | SUPPL-18 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20220scp018_ultravist_lbl.pdf |