Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017903
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENOVUE-DIP IODAMIDE MEGLUMINE 24% 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 3 - New Dosage Form 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-9 Labeling

Label is not available on this site.

03/21/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1985 SUPPL-7 Labeling

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)-Expiration Date

Label is not available on this site.

11/23/1982 SUPPL-4 Efficacy

Label is not available on this site.

01/22/1980 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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