MedPath
FDA Approval

QUVIVIQ

November 2, 2023

HUMAN PRESCRIPTION DRUG LABEL

Daridorexant(25 mg in 1 1)

Products (2)

QUVIVIQ

80491-7825

NDA214985

NDA (C73594)

ORAL

October 31, 2023

TalcInactive
Code: 7SEV7J4R1UClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Code: LMQ24G57E9Class: ACTIBQuantity: 25 mg in 1 1
MannitolInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
Povidone K30Inactive
Code: U725QWY32XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

QUVIVIQ

80491-7850

NDA214985

NDA (C73594)

ORAL

October 31, 2023

TalcInactive
Code: 7SEV7J4R1UClass: IACT
Silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Code: LMQ24G57E9Class: ACTIBQuantity: 50 mg in 1 1
MannitolInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMKClass: IACT
Povidone K30Inactive
Code: U725QWY32XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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