Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Braintree Laboratories, Inc.
Affordable Pharmaceuticals, LLC
617357954
Products2
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
Product Details
NDC Product Code
10572-012Application Number
NDA022372Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 5, 2022SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MALIC ACIDInactive
Code: 817L1N4CKPClass: IACT
Potassium sulfateActive
Code: 1K573LC5TVClass: ACTIBQuantity: 3.13 g in 1 mL
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
Sodium sulfateActive
Code: 0YPR65R21JClass: ACTIBQuantity: 17.5 g in 1 mL
Code: DE08037SABClass: ACTIBQuantity: 1.6 g in 1 mL
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Product Details
NDC Product Code
10572-112Application Number
NDA022372Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 5, 2022SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MALIC ACIDInactive
Code: 817L1N4CKPClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
Sodium sulfateActive
Code: 0YPR65R21JClass: ACTIBQuantity: 13.13 g in 133.1 mL
Potassium sulfateActive
Code: 1K573LC5TVClass: ACTIBQuantity: 2.35 g in 133.1 mL
Code: DE08037SABClass: ACTIBQuantity: 1.2 g in 133.1 mL