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FDA ANDA · ANDA204071

SODIUM POLYSTYRENE SULFONATE

Sponsor: NUVO PHARMS INC

APPLICATION
ANDA204071
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-28
LATEST ACTION
2020-02-21
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

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

Approval history

2020-02-21Labeling · Supplement 3 · standardAP
2014-11-28UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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