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KOMBIGLYZE XR (nda200678)- (1GM;EQ 5MG BASE,1GM;EQ 2.5MG BASE,500MG;EQ 5MG BASE)

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB
1GM;EQ 5MG BASE,1GM;EQ 2.5MG BASE,500MG;EQ 5MG BASE
Yes No
2025-Oct-14 2014-Jul-31
None None
None No
KOMBIGLYZE XR is a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.
4 1 2
Total Other Developers 4
Drugs with Suitability No
1GM;EQ 5MG BASE ** ** Up - 2
1GM;EQ 2.5MG BASE ** ** Up - 2
500MG;EQ 5MG BASE ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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