Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
BrainTree Laboratories, Inc.
Braintree Laboratories, Inc.
617357954
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SUPREP Bowel Prep
Product Details
NDC Product Code
52268-112Application Number
NDA022372Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 18, 2020SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MALIC ACIDInactive
Code: 817L1N4CKPClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
Potassium sulfateActive
Code: 1K573LC5TVClass: ACTIBQuantity: 2.35 g in 133.1 mL
Sodium sulfateActive
Code: 0YPR65R21JClass: ACTIBQuantity: 13.13 g in 133.1 mL
Code: DE08037SABClass: ACTIBQuantity: 1.2 g in 133.1 mL
SUPREP Bowel Prep
Product Details
NDC Product Code
52268-012Application Number
NDA022372Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
August 18, 2020SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
MALIC ACIDInactive
Code: 817L1N4CKPClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
Sodium sulfateActive
Code: 0YPR65R21JClass: ACTIBQuantity: 17.5 g in 1 mL
Potassium sulfateActive
Code: 1K573LC5TVClass: ACTIBQuantity: 3.13 g in 1 mL
Code: DE08037SABClass: ACTIBQuantity: 1.6 g in 1 mL