USFDA APPLICATION NUMBER - 200678 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N) | metformin hydrochloride | 1000mg | 1000mg | 500mg |
saxagliptin hydrochloride(UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ) | saxagliptin anhydrous | 2.5mg | 5mg | 5mg |
Inactive Ingredients
Ingredient Name | E.R. Squibb & Sons, L.L.C. |
---|---|
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311) | |
cellulose, microcrystalline(OP1R32D61U) | |
hypromellose 2208 (15000 mpa.s)(Z78RG6M2N2) | |
hypromellose 2910 (15 mpa.s)(36SFW2JZ0W) | |
magnesium stearate(70097M6I30) |
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