Manufacturing Establishments (1)
HIKMA FARMACEUTICA (PORTUGAL), S.A
Hikma Pharmaceuticals USA Inc.
452742943
Products (2)
Flumazenil
0143-9684
ANDA078527
ANDA (C73584)
INTRAVENOUS
November 20, 2023
FlumazenilActive
Code: 40P7XK9392Class: ACTIBQuantity: 0.1 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.1 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9.0 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Flumazenil
0143-9683
ANDA078527
ANDA (C73584)
INTRAVENOUS
November 20, 2023
FlumazenilActive
Code: 40P7XK9392Class: ACTIBQuantity: 0.1 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.1 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9.0 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT