MedPath
FDA Approval

STEGLUJAN

October 20, 2023

HUMAN PRESCRIPTION DRUG LABEL

Sitagliptin(100 mg in 1 1)

Products (2)

STEGLUJAN

0006-5367

NDA209805

NDA (C73594)

ORAL

October 20, 2023

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: MLU731K321Class: ACTIMQuantity: 5 mg in 1 1
Code: TS63EW8X6FClass: ACTIMQuantity: 100 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT

STEGLUJAN

0006-5368

NDA209805

NDA (C73594)

ORAL

October 20, 2023

Code: MLU731K321Class: ACTIMQuantity: 15 mg in 1 1
Code: TS63EW8X6FClass: ACTIMQuantity: 100 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
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