SUTAB
These highlights do not include all the information needed to use SUTAB safely and effectively. See full prescribing information for SUTAB. SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
dddd2701-4d46-44de-a9f8-303d4dcceef7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Braintree Laboratories, Inc.
DUNS: 107904591
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium sulfate, magnesium sulfate, and potassium chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52268-201
Application NumberNDA213135
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium sulfate, magnesium sulfate, and potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (7)
POTASSIUM CHLORIDEActive
Quantity: 2.25 g in 1 1
Code: 660YQ98I10
Classification: ACTIM
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM CAPRYLATEInactive
Code: 9XTM81VK2B
Classification: IACT
ETHYLENE GLYCOLInactive
Code: FC72KVT52F
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
SODIUM SULFATEActive
Quantity: 17.75 g in 1 1
Code: 0YPR65R21J
Classification: ACTIB
MAGNESIUM SULFATE ANHYDROUSActive
Quantity: 2.7 g in 1 1
Code: ML30MJ2U7I
Classification: ACTIB