Registrants (1)
Manufacturing Establishments (1)
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
Fresenius Kabi USA, LLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
421324417
Products (2)
Gadobutrol
65219-287
ANDA216081
ANDA (C73584)
INTRAVENOUS
September 14, 2023
GadobutrolActive
Code: 1BJ477IO2LClass: ACTIBQuantity: 604.72 mg in 1 mL
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
TromethamineInactive
Code: 023C2WHX2VClass: IACT
Calcobutrol SodiumInactive
Code: PO5286589KClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Gadobutrol
65219-289
ANDA216081
ANDA (C73584)
INTRAVENOUS
September 14, 2023
GadobutrolActive
Code: 1BJ477IO2LClass: ACTIBQuantity: 604.72 mg in 1 mL
TromethamineInactive
Code: 023C2WHX2VClass: IACT
Calcobutrol SodiumInactive
Code: PO5286589KClass: IACT
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT