APPLICATION
ANDA089910
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-19
LATEST ACTION
2018-01-29
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
SODIUM POLYSTYRENE SULFONATEPrescription
SODIUM POLYSTYRENE SULFONATE 454GM/BOT · POWDER · ORAL, RECTAL
Approval history
2018-01-29Labeling · Supplement 9 · standardAP
2012-09-25Labeling · Supplement 8 · standardAP
2000-10-31Manufacturing (CMC) · Supplement 5AP
1992-11-04Labeling · Supplement 4AP
1991-12-04Manufacturing (CMC) · Supplement 3AP
1989-01-19OriginalAP
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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