Registrants (1)
Braintree Laboratories, Inc.
617357954
Manufacturing Establishments (1)
Braintree Laboratories, Inc.
Affordable Pharmaceuticals, LLC
Braintree Laboratories, Inc.
617357954
Products (1)
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
10572-302
NDA019797
NDA authorized generic (C73605)
ORAL
May 3, 2021
Polyethylene glycolActive
Code: G2M7P15E5PClass: ACTIBQuantity: 420 g in 4 L
Sodium bicarbonateActive
Code: 8MDF5V39QOClass: ACTIBQuantity: 5.72 g in 4 L
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 11.2 g in 4 L
Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 1.48 g in 4 L