MedPath
FDA Approval

JANUMET

January 9, 2024

HUMAN PRESCRIPTION DRUG LABEL

Sitagliptin(50 mg in 1 1)
Metformin(500 mg in 1 1)

Products (2)

JANUMET

0006-0575

NDA022044

NDA (C73594)

ORAL

July 22, 2022

Code: TS63EW8X6FClass: ACTIMQuantity: 50 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 500 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT

JANUMET

0006-0577

NDA022044

NDA (C73594)

ORAL

July 22, 2022

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: TS63EW8X6FClass: ACTIMQuantity: 50 mg in 1 1
MetforminActive
Code: 786Z46389EClass: ACTIBQuantity: 1000 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
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