MedPath
FDA Approval

BELSOMRA

February 28, 2023

HUMAN PRESCRIPTION DRUG LABEL

Suvorexant(10 mg in 1 1)

Products (4)

BELSOMRA

0006-0033

NDA204569

NDA (C73594)

ORAL

February 28, 2023

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: 081L192FO9Class: ACTIBQuantity: 10 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT

BELSOMRA

0006-0325

NDA204569

NDA (C73594)

ORAL

February 28, 2023

Code: 081L192FO9Class: ACTIBQuantity: 15 mg in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT

BELSOMRA

0006-0335

NDA204569

NDA (C73594)

ORAL

February 28, 2023

Code: 081L192FO9Class: ACTIBQuantity: 20 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT

BELSOMRA

0006-0005

NDA204569

NDA (C73594)

ORAL

February 28, 2023

Code: 081L192FO9Class: ACTIBQuantity: 5 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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