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
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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Product Details
NDC Product Code
52268-100Application Number
NDA019011Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 28, 2021Polyethylene glycolActive
Code: G2M7P15E5PClass: ACTIBQuantity: 236 g in 4 L
Sodium sulfateActive
Code: 36KCS0R750Class: ACTIBQuantity: 22.74 g in 4 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 6.74 g in 4 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 5.86 g in 4 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 2.97 g in 4 L
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Product Details
NDC Product Code
52268-700Application Number
NDA019011Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 28, 2021Polyethylene glycolActive
Code: G2M7P15E5PClass: ACTIBQuantity: 227.1 g in 1 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 5.53 g in 1 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 0.754 g in 1 L
Sodium sulfateActive
Code: 36KCS0R750Class: ACTIBQuantity: 21.5 g in 1 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 6.36 g in 1 L
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Product Details
NDC Product Code
52268-101Application Number
NDA019011Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
May 28, 2021Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 5.86 g in 4 L
Sodium sulfateActive
Code: 36KCS0R750Class: ACTIBQuantity: 22.74 g in 4 L
Polyethylene glycolActive
Code: G2M7P15E5PClass: ACTIBQuantity: 236 g in 4 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 6.74 g in 4 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 2.97 g in 4 L