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FDA NDA · NDA011287

KAYEXALATE

Sponsor: CONCORDIA

APPLICATION
NDA011287
TYPE
NDA
ORIGINAL APPROVAL
1958-06-05
LATEST ACTION
2017-07-28
ROUTE
ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

KAYEXALATE · ReferenceDiscontinued
SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · ORAL, RECTAL

Approval history

2017-07-28Labeling · Supplement 26 · standard — Label ↗AP
2014-01-13Manufacturing (CMC) · Supplement 24 · priorityAP
2011-01-03Labeling · Supplement 23 · unknown — Letter ↗AP
2009-09-02Labeling · Supplement 22 · standard — Label ↗AP
2009-04-24Labeling · Supplement 21 · standard — Letter ↗AP
2003-12-05Labeling · Supplement 18 · standard — Letter ↗AP
2003-05-09Labeling · Supplement 17 · standard — Letter ↗AP
1991-10-21Labeling · Supplement 16AP
1991-05-07Labeling · Supplement 11AP
1988-10-25Manufacturing (CMC) · Supplement 15 · priorityAP
1987-08-25Manufacturing (CMC) · Supplement 14 · priorityAP
1985-02-08Manufacturing (CMC) · Supplement 12 · priorityAP
1984-09-24Labeling · Supplement 13AP
1982-08-06Manufacturing (CMC) · Supplement 10 · priorityAP
1980-07-17Labeling · Supplement 9AP
1979-10-05Labeling · Supplement 8AP
1977-08-30Labeling · Supplement 7AP
1977-08-22Labeling · Supplement 6AP
1958-06-05Type 1 - New Molecular Entity · Original · priorityAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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