SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE
These highlights do not include all the information needed to use SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE safely and effectively. See full prescribing information for SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE. SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE (sodium sulfate, potassium sulfate, magnesium sulfate) SOLUTION for ORAL use.Initial U.S. Approval: 2010
Approved
Approval ID
d4883657-d27d-4056-a567-5fb12d5e05d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 1
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 Code43386-700
Application NumberANDA202511
Product Classification
M
Marketing Category
C73584
G
Generic Name
sodium sulfate, potassium sulfate, magnesium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM SULFATE ANHYDROUSActive
Quantity: 1.6 g in 177 mL
Code: ML30MJ2U7I
Classification: ACTIB
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM SULFATEActive
Quantity: 3.13 g in 177 mL
Code: 1K573LC5TV
Classification: ACTIB
SODIUM SULFATEActive
Quantity: 17.5 g in 177 mL
Code: 0YPR65R21J
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT