Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
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, for oral useInitial U.S. Approval: 2010
Approved
Approval ID
d48d8c59-68b9-4e28-86a4-eabf8b2003b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
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 and Magnesium Sulfate Oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-116
Application NumberANDA215469
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (7)
SODIUM SULFATEActive
Quantity: 17.5 g in 177 mL
Code: 0YPR65R21J
Classification: ACTIB
POTASSIUM SULFATEActive
Quantity: 3.13 g in 177 mL
Code: 1K573LC5TV
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMActive
Quantity: 1.6 g in 177 mL
Code: DE08037SAB
Classification: ACTIB