Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019565
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER AMINO ACIDS; DEXTROSE 5%;25GM/100ML 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
12/17/1986 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
06/27/1987 SUPPL-3 Labeling

Label is not available on this site.

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