Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017902
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENOVUE-65 IODAMIDE MEGLUMINE 65% 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
07/25/1978 ORIG-1 Approval Type 2 - New Active Ingredient 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
05/11/1995 SUPPL-8 Labeling

Label is not available on this site.

03/21/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/22/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1983 SUPPL-4 Efficacy

Label is not available on this site.

07/04/1980 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1980 SUPPL-1 Labeling

Label is not available on this site.

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