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Sodium Polystyrene Sulfonate

These highlights do not include all the information needed to use SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION safely and effectively. See full prescribing information for SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION, for oral or rectal use Initial U.S. Approval: 1958

Approved
Approval ID

2017bfbe-cda8-46f1-b4f1-9c086c3249a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2021

Manufacturers
FDA

CMP Pharma, Inc.

DUNS: 005224175

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Polystyrene Sulfonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46287-012
Application NumberANDA089910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Polystyrene Sulfonate
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateNovember 30, 2017
FDA Product Classification

INGREDIENTS (1)

SODIUM POLYSTYRENE SULFONATEActive
Quantity: 1 g in 1 g
Code: 1699G8679Z
Classification: ACTIB

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Sodium Polystyrene Sulfonate - FDA Drug Approval Details