MedPath
FDA Approval

Gadobutrol

September 14, 2023

HUMAN PRESCRIPTION DRUG LABEL

Gadobutrol(604.72 mg in 1 mL)

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

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

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
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