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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018893
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM ACETATE SODIUM ACETATE 40MEQ/20ML (2MEQ/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
SODIUM ACETATE SODIUM ACETATE 100MEQ/50ML (2MEQ/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
SODIUM ACETATE SODIUM ACETATE 200MEQ/100ML (2MEQ/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/02/2014 SUPPL-25 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018893s025lbl.pdf
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