Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 650738743

Effective Date

January 17, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Products1

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

NDC Product Code

64380-116

Application Number

ANDA215469

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2024

Ingredients

Code: 0YPR65R21JClass: ACTIBQuantity: 17.5 g in 177 mL

Code: 1K573LC5TVClass: ACTIBQuantity: 3.13 g in 177 mL

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

MALIC ACIDInactive

Code: 817L1N4CKPClass: IACT

Code: DE08037SABClass: ACTIBQuantity: 1.6 g in 177 mL