Edarbyclor

Products (2)

NDC Product Code

60631-412

Application Number

NDA202331

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 1, 2022

Ingredients

Azilsartan KamedoxomilActive

Code: WEC6I2K1FCClass: ACTIRQuantity: 40 mg in 1 1

ChlorthalidoneActive

Code: Q0MQD1073QClass: ACTIBQuantity: 12.5 mg in 1 1

mannitolInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

polyethylene glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

Edarbyclor

NDC Product Code

60631-425

Application Number

NDA202331

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 1, 2022

Ingredients

Azilsartan KamedoxomilActive

Code: WEC6I2K1FCClass: ACTIRQuantity: 40 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ChlorthalidoneActive

Code: Q0MQD1073QClass: ACTIBQuantity: 25 mg in 1 1

waterInactive

Code: 059QF0KO0RClass: IACT

mannitolInactive

Code: 3OWL53L36AClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

polyethylene glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

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Edarbyclor

Products (2)

Edarbyclor

Edarbyclor