Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018735
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 None 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 None Yes Yes
ISOVUE-M 300 IOPAMIDOL 61% INJECTABLE;INJECTION Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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