USFDA APPLICATION NUMBER - 205879 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
canagliflozin(UNII: 0SAC974Z85) (canagliflozin anhydrous - UNII:6S49DGR869) | canagliflozin anhydrous | 150mg | 150mg | 50mg | 50mg |
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N) | metformin hydrochloride | 1000mg | 500mg | 500mg | 1000mg |
Inactive Ingredients
Ingredient Name | Janssen Pharmaceuticals, Inc. |
---|---|
anhydrous lactose(3SY5LH9PMK) | |
croscarmellose sodium(M28OL1HH48) | |
ferric oxide red(1K09F3G675) | |
ferric oxide yellow(EX438O2MRT) | |
ferrosoferric oxide(XM0M87F357) | |
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P) | |
hypromellose, unspecified(3NXW29V3WO) | |
magnesium stearate(70097M6I30) | |
microcrystalline cellulose(OP1R32D61U) | |
polyethylene glycol, unspecified(3WJQ0SDW1A) | |
polyvinyl alcohol, unspecified(532B59J990) | |
talc(7SEV7J4R1U) | |
titanium dioxide(15FIX9V2JP) |
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