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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009321
Company: BRACCO

Products on NDA 009321

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009321

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.

Labels for NDA 009321

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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