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FDA ANDA · ANDA087859

SODIUM POLYSTYRENE SULFONATE

Sponsor: CMP PHARMA INC

APPLICATION
ANDA087859
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-08
LATEST ACTION
2011-06-24
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

SPS · ReferencePrescription
SODIUM POLYSTYRENE SULFONATE 15GM/60ML · SUSPENSION · ORAL, RECTAL

Approval history

2011-06-24Labeling · Supplement 25AP
2011-03-03Labeling · Supplement 23AP
2011-03-03Labeling · Supplement 24AP
2004-03-18Labeling · Supplement 20AP
2000-11-30Manufacturing (CMC) · Supplement 18AP
1991-12-12Labeling · Supplement 13AP
1991-05-31Manufacturing (CMC) · Supplement 14AP
1989-07-18Manufacturing (CMC) · Supplement 12AP
1987-07-16Manufacturing (CMC) · Supplement 10AP
1985-12-12Manufacturing (CMC) · Supplement 3AP
1983-04-27Manufacturing (CMC) · Supplement 1AP
1982-12-08OriginalAP
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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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