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FDA ANDA · ANDA040905

SODIUM POLYSTYRENE SULFONATE

Sponsor: KVK TECH

APPLICATION
ANDA040905
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-30
LATEST ACTION
2020-02-21
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

KALEXATEPrescription
SODIUM POLYSTYRENE SULFONATE 15GM/BOT · POWDER · ORAL, RECTAL
KALEXATEPrescription
SODIUM POLYSTYRENE SULFONATE 454GM/BOT · POWDER · ORAL, RECTAL

Approval history

2020-02-21Labeling · Supplement 6 · standardAP
2011-11-08Labeling · Supplement 4AP
2009-03-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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