MedPath
FDA Approval

Flumazenil

January 22, 2020

Human Prescription Drug Label

Flumazenil(0.1 mg in 1 mL)

Manufacturing Establishments (1)

Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC

023648251

Products (1)

Flumazenil

63323-424

ANDA076955

ANDA (C73584)

INTRAVENOUS

October 20, 2017

Code: 40P7XK9392Class: ACTIBQuantity: 0.1 mg in 1 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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