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FDA Approval

LACTATED RINGERS AND DEXTROSE

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

February 20, 2020

HUMAN PRESCRIPTION DRUG LABEL

Lactic acid(310 mg in 100 mL)
Glucose(5 g in 100 mL)
Sodium chloride(600 mg in 100 mL)
Potassium chloride(30 mg in 100 mL)
Calcium chloride(20 mg in 100 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 (2)

LACTATED RINGERS AND DEXTROSE

51662-1229

NDA017608

NDA (C73594)

INTRAVENOUS

February 20, 2020

Code: TU7HW0W0QTClass: ACTIBQuantity: 310 mg in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 5 g in 100 mL
Code: 451W47IQ8XClass: ACTIBQuantity: 600 mg in 100 mL
Code: 660YQ98I10Class: ACTIBQuantity: 30 mg in 100 mL
Code: M4I0D6VV5MClass: ACTIBQuantity: 20 mg in 100 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

LACTATED RINGERS

51662-1300

NDA017641

NDA (C73594)

INTRAVENOUS

February 20, 2020

Code: TU7HW0W0QTClass: ACTIBQuantity: 310 mg in 100 mL
Code: M4I0D6VV5MClass: ACTIBQuantity: 20 mg in 100 mL
Code: 660YQ98I10Class: ACTIBQuantity: 30 mg in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: 451W47IQ8XClass: ACTIBQuantity: 600 mg in 100 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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