SUPREP Bowel Prep
These highlights do not include all the information needed to use SUPREP Bowel Prep Kit safely and effectively. See full prescribing information for SUPREP Bowel Prep Kit SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution Initial U.S. Approval: 08/2010
Approved
Approval ID
2f5f06de-ee98-44c0-be7e-9a998d1e5c16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2020
Manufacturers
FDA
Braintree Laboratories, Inc.
DUNS: 107904591
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 Code52268-112
Application NumberNDA022372
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium sulfate, potassium sulfate, magnesium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2020
FDA Product Classification
INGREDIENTS (7)
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POTASSIUM SULFATEActive
Quantity: 2.35 g in 133.1 mL
Code: 1K573LC5TV
Classification: ACTIB
SODIUM SULFATEActive
Quantity: 13.13 g in 133.1 mL
Code: 0YPR65R21J
Classification: ACTIB
MAGNESIUM SULFATE, UNSPECIFIED FORMActive
Quantity: 1.2 g in 133.1 mL
Code: DE08037SAB
Classification: ACTIB
sodium sulfate, potassium sulfate, magnesium sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52268-012
Application NumberNDA022372
Product Classification
M
Marketing Category
C73594
G
Generic Name
sodium sulfate, potassium sulfate, magnesium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2020
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: 17.5 g in 1 mL
Code: 0YPR65R21J
Classification: ACTIB
POTASSIUM SULFATEActive
Quantity: 3.13 g in 1 mL
Code: 1K573LC5TV
Classification: ACTIB
MAGNESIUM SULFATE, UNSPECIFIED FORMActive
Quantity: 1.6 g in 1 mL
Code: DE08037SAB
Classification: ACTIB