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JANUMET - SITAGLIPTIN and METFORMIN HYDROCHLORIDE

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Field Value
NDC Code: 52125-486
Proprietary Name: JANUMET
Suffix:
Non-Proprietary Name: SITAGLIPTIN and METFORMIN HYDROCHLORIDE
Dosage Form: TABLET, FILM COATED
Method: ORAL
Original Marketing Date: 22-05-2013
Category Name: NDA
Application Number: NDA022044
Labeler: REMEDYREPACK INC.
Substance Name: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Active Numerator Strength: 500; 50
Active Ingredient Unit: mg/1; mg/1
Pharm Classes: Biguanide [EPC],Biguanides [Chemical/Ingredient],Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
DEA Schedule: