Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020107
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER AMINO ACIDS 15% (15GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
02/05/1993 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

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