MedPath
FDA Approval

FLUMAZENIL

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

June 28, 2021

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

51662-1579

ANDA076955

ANDA (C73584)

INTRAVENOUS

June 28, 2021

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