APPLICATION
ANDA040029
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-06
LATEST ACTION
2020-03-16
ROUTE
ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
KIONEXPrescription
SODIUM POLYSTYRENE SULFONATE 454GM/BOT · POWDER · ORAL, RECTAL
Approval history
2020-03-16Labeling · Supplement 17 · standardAP
2012-09-26Labeling · Supplement 16AP
2011-12-08Labeling · Supplement 15AP
1998-02-06OriginalAP
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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