APPLICATION
ANDA040028
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-17
LATEST ACTION
2024-05-03
ROUTE
ORAL, ORAL, RECTAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
KIONEXPrescription
SODIUM POLYSTYRENE SULFONATE 15GM/60ML · SUSPENSION · ORAL, RECTAL
Approval history
2024-05-03Manufacturing (CMC) · Supplement 19 · unknownAP
2022-10-18Labeling · Supplement 14 · standardAP
2015-04-26Labeling · Supplement 12AP
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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