Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 015419
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HIPPUTOPE IODOHIPPURATE SODIUM I-131 1-2mCi/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
06/25/1970 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
09/30/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/12/1985 SUPPL-12 Labeling

Label is not available on this site.

06/08/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

03/13/2009 SUPPL-7 Labeling

Label is not available on this site.

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