MedPath
FDA Approval

Flumazenil

September 28, 2011

HUMAN PRESCRIPTION DRUG LABEL

Flumazenil(0.1 mg in 1 mL)

Products (2)

Flumazenil

0641-6032

ANDA076787

ANDA (C73584)

INTRAVENOUS

September 28, 2011

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
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Flumazenil

0641-6031

ANDA076787

ANDA (C73584)

INTRAVENOUS

September 28, 2011

METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL
Code: 40P7XK9392Class: ACTIBQuantity: 0.1 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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