Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016224
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROBENGATOPE ROSE BENGAL SODIUM I-131 0.5mCi/VIAL INJECTABLE;INJECTION Discontinued None No No
ROBENGATOPE ROSE BENGAL SODIUM I-131 1mCi/VIAL INJECTABLE;INJECTION Discontinued None No No
ROBENGATOPE ROSE BENGAL SODIUM I-131 2mCi/VIAL 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
11/23/1971 ORIG-1 Approval Type 1 - New Molecular Entity 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
06/11/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1976 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/01/1976 SUPPL-4 Labeling

Label is not available on this site.

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