MedPath
FDA Approval

FLOLAN

October 26, 2023

HUMAN PRESCRIPTION DRUG LABEL

Water(1 mL in 1 mL)

Products (3)

Diluent

0173-0857

NDA020444

NDA (C73594)

INTRAVENOUS

August 24, 2021

WaterActive
Code: 059QF0KO0RClass: ACTIBQuantity: 1 mL in 1 mL
GLYCINEInactive
Code: TE7660XO1CClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

FLOLAN

0173-0519

NDA020444

NDA (C73594)

INTRAVENOUS

August 24, 2021

Code: 4K04IQ1OF4Class: ACTIMQuantity: 1.5 mg in 1 1
GLYCINEInactive
Code: TE7660XO1CClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT

FLOLAN

0173-0517

NDA020444

NDA (C73594)

INTRAVENOUS

August 24, 2021

Code: 4K04IQ1OF4Class: ACTIMQuantity: 0.5 mg in 1 1
GLYCINEInactive
Code: TE7660XO1CClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
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