KOMBIGLYZE - SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
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Field |
Value |
NDC Code: |
0003-4222 |
Proprietary Name: |
KOMBIGLYZE |
Suffix: |
XR |
Non-Proprietary Name: |
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
Dosage Form: |
TABLET, FILM COATED, EXTENDED RELEASE |
Method: |
ORAL |
Original Marketing Date: |
05-11-2010 |
Category Name: |
NDA |
Application Number: |
NDA200678 |
Labeler: |
E.R. SQUIBB & SONS, L.L.C. |
Substance Name: |
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
Active Numerator Strength: |
1000; 2.5 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] |
DEA Schedule: |
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