Registrants (1)
Slate Run Pharmaceuticals, LLC
039452765
Manufacturing Establishments (1)
Hainan Poly Pharm. Co., Ltd.
Slate Run Pharmaceuticals, LLC
Slate Run Pharmaceuticals, LLC
654561638
Products (2)
gadobutrol
70436-216
ANDA217480
ANDA (C73584)
INTRAVENOUS
April 17, 2025
CALCOBUTROL SODIUMInactive
Code: PO5286589KClass: IACT
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
GadobutrolActive
Code: 1BJ477IO2LClass: ACTIBQuantity: 604.72 mg in 1 mL
gadobutrol
70436-217
ANDA217480
ANDA (C73584)
INTRAVENOUS
April 17, 2025
CALCOBUTROL SODIUMInactive
Code: PO5286589KClass: IACT
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
GadobutrolActive
Code: 1BJ477IO2LClass: ACTIBQuantity: 604.72 mg in 1 mL