Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018735
Company: BRACCO
Company: BRACCO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOVUE-128 | IOPAMIDOL | 26% | INJECTABLE;INJECTION | Discontinued | None | No | No |
ISOVUE-200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | AP2 | Yes | Yes |
ISOVUE-250 | IOPAMIDOL | 51% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
ISOVUE-300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
ISOVUE-370 | IOPAMIDOL | 76% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
ISOVUE-M 200 | IOPAMIDOL | 41% | INJECTABLE;INJECTION | Prescription | AP1 | Yes | Yes |
ISOVUE-M 300 | IOPAMIDOL | 61% | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/25/2023 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018735s070lbl.pdf | |
02/18/2022 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018735s067lbl.pdf | |
04/05/2017 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018735s057lbl.pdf | |
07/06/2015 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf | |
08/01/2012 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018735s054lbl.pdf |