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SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

These highlights do not include all the information needed to use SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL SOLUTION SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL SOLUTION Initial U.S. Approval: 2010

Approved
Approval ID

f86bdcc8-e643-4160-89ae-01c89bee842d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 5, 2022

Manufacturers
FDA

Affordable Pharmaceuticals, LLC

DUNS: 182815311

Products 2

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

sodium sulfate, potassium sulfate, magnesium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10572-012
Application NumberNDA022372
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium sulfate, potassium sulfate, magnesium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2022
FDA Product Classification

INGREDIENTS (7)

SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
POTASSIUM SULFATEActive
Quantity: 3.13 g in 1 mL
Code: 1K573LC5TV
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM SULFATEActive
Quantity: 17.5 g in 1 mL
Code: 0YPR65R21J
Classification: ACTIB
MAGNESIUM SULFATE, UNSPECIFIED FORMActive
Quantity: 1.6 g in 1 mL
Code: DE08037SAB
Classification: ACTIB

sodium sulfate, potassium sulfate, magnesium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10572-112
Application NumberNDA022372
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium sulfate, potassium sulfate, magnesium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2022
FDA Product Classification

INGREDIENTS (7)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM SULFATEActive
Quantity: 13.13 g in 133.1 mL
Code: 0YPR65R21J
Classification: ACTIB
POTASSIUM SULFATEActive
Quantity: 2.35 g in 133.1 mL
Code: 1K573LC5TV
Classification: ACTIB
MAGNESIUM SULFATE, UNSPECIFIED FORMActive
Quantity: 1.2 g in 133.1 mL
Code: DE08037SAB
Classification: ACTIB

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SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE - FDA Drug Approval Details