Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020327
Company: BRACCO
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOVUE-200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Discontinued | None | No | No |
ISOVUE-250 | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
ISOVUE-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
ISOVUE-370 | IOPAMIDOL | 76% | 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 |
---|---|---|---|---|---|---|---|
10/12/1994 | 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-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020327s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018735Orig1s070;020327Orig1s025ltr.pdf | |
02/18/2022 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020327s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018735Orig1s067; 020327Orig1s023ltr.pdf | |
02/16/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020327s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020327Orig1s014ltr.pdf | |
04/05/2017 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020327s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018735Orig1s057,020327Orig1s012ltr.pdf | |
01/22/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020327s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020327Orig1s011ltr.pdf | |
07/06/2015 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf | |
06/20/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020327s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020327Orig1s008ltr.pdf | |
08/01/2012 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020327Orig1s007ltr.pdf | |
07/26/2005 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/05/2003 | SUPPL-4 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf |
12/09/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/20/2002 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20327slr002ltr.pdf |
12/17/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
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-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020327s025lbl.pdf | |
02/18/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020327s023lbl.pdf | |
02/16/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020327s014lbl.pdf | |
04/05/2017 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020327s012lbl.pdf | |
01/22/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020327s011lbl.pdf | |
07/06/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf | |
06/20/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020327s008lbl.pdf | |
08/01/2012 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf |