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SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** POWDER;ORAL, RECTAL Discontinued None Yes No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
06/05/1958 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/011287s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011287Orig1s026ltr.pdf
01/13/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/03/2011 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011287s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011287s023ltr.pdf
09/02/2009 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s022ltr.pdf
04/24/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/011287s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011287s021ltr.pdf
12/05/2003 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11287slr018ltr.pdf
05/09/2003 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/11287slr017ltr.pdf
10/21/1991 SUPPL-16 Labeling

Label is not available on this site.

10/25/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/25/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/24/1984 SUPPL-13 Labeling

Label is not available on this site.

02/08/1985 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/07/1991 SUPPL-11 Labeling

Label is not available on this site.

08/06/1982 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1980 SUPPL-9 Labeling

Label is not available on this site.

10/05/1979 SUPPL-8 Labeling

Label is not available on this site.

08/30/1977 SUPPL-7 Labeling

Label is not available on this site.

08/22/1977 SUPPL-6 Labeling

Label is not available on this site.

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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