Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020327
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 Prescription None Yes Yes
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
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
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

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