An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 011287
Company: CONCORDIA

Products on NDA 011287

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KAYEXALATE	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER;ORAL, RECTAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011287

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.

Labels for NDA 011287

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

Top