MedPath
FDA Approval

FLUMAZENIL

HF Acquisition Co. LLC, DBA HealthFirst (DUNS: 045657305)

January 28, 2024

HUMAN PRESCRIPTION DRUG LABEL

Flumazenil(0.1 mg in 1 mL)

Registrants (1)

HF Acquisition Co. LLC, DBA HealthFirst

045657305

Manufacturing Establishments (1)

HF Acquisition Co. LLC, DBA HealthFirst

HF Acquisition Co. LLC, DBA HealthFirst

HF Acquisition Co. LLC, DBA HealthFirst

045657305

Products (1)

FLUMAZENIL

51662-1254

ANDA078527

ANDA (C73584)

INTRAVENOUS

January 28, 2024

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