Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009321
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHOLOGRAFIN MEGLUMINE IODIPAMIDE MEGLUMINE 52% INJECTABLE;INJECTION Discontinued None Yes No
CHOLOGRAFIN MEGLUMINE IODIPAMIDE MEGLUMINE 10.3% INJECTABLE;INJECTION Discontinued None No No
CHOLOGRAFIN SODIUM IODIPAMIDE SODIUM 20% INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/27/1954 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
04/05/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009321s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009321Orig1s030ltr.pdf
07/06/2015 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009321Orig1s028ltr.pdf
03/16/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/11/1995 SUPPL-23 Labeling

Label is not available on this site.

04/29/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/12/1982 SUPPL-18 Labeling

Label is not available on this site.

10/01/1979 SUPPL-17 Labeling

Label is not available on this site.

05/16/1977 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1977 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1976 SUPPL-14 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/05/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009321s030lbl.pdf
07/06/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009321s028lbl.pdf

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