MedPath
FDA Approval

Edarbi

January 23, 2024

HUMAN PRESCRIPTION DRUG LABEL

Products (2)

Edarbi

60631-040

NDA200796

NDA (C73594)

ORAL

January 29, 2024

croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
Code: WEC6I2K1FCClass: ACTIRQuantity: 40 mg in 1 1
fumaric acidInactive
Code: 88XHZ13131Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT

Edarbi

60631-080

NDA200796

NDA (C73594)

ORAL

January 29, 2024

Code: WEC6I2K1FCClass: ACTIRQuantity: 80 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
fumaric acidInactive
Code: 88XHZ13131Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
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