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: |
|