Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020686
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUMENHANCE MANGANESE CHLORIDE TETRAHYDRATE 3.49MG/GM FOR SOLUTION;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
12/19/1997 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

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