Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012968
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORAGRAFIN CALCIUM IPODATE CALCIUM 3GM/PACKET GRANULE;ORAL 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
03/15/1962 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/06/1991 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1979 SUPPL-10 Labeling

Label is not available on this site.

06/08/1978 SUPPL-8 Labeling

Label is not available on this site.

09/09/1976 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/24/1975 SUPPL-6 Labeling

Label is not available on this site.

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