Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011287
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KAYEXALATE SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER;ORAL, RECTAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011287s026lbl.pdf
01/03/2011 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011287s023lbl.pdf
09/02/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf
04/24/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s021lbl.pdf

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