Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011620
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIOGRAFIN DIATRIZOATE MEGLUMINE 85% 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
12/03/1958 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
01/28/1985 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/11/1985 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/05/1982 SUPPL-22 Labeling

Label is not available on this site.

07/29/1980 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1978 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/27/1978 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1977 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1977 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1976 SUPPL-12 Labeling

Label is not available on this site.

09/14/1976 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/10/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

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