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USFDA APPLICATION NUMBER - 22024 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N) | metformin hydrochloride | 1000mg | 1000mg |
| pioglitazone hydrochloride(UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S) | pioglitazone | 30mg | 15mg |
Inactive Ingredients
| Ingredient Name | Takeda Pharmaceuticals America, Inc. |
|---|---|
| Aluminum Oxide(LMI26O6933) | |
| ammonia(5138Q19F1X) | |
| candelilla wax(WL0328HX19) | |
| cellulose acetate(3J2P07GVB6) | |
| FD&C Blue No. 2(L06K8R7DQK) | |
| ferric oxide red(1K09F3G675) | |
| HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P) | |
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |
| lactose monohydrate(EWQ57Q8I5X) | |
| magnesium stearate(70097M6I30) | |
| polyethylene glycol 400(B697894SGQ) | |
| polyethylene glycol 8000(Q662QK8M3B) | |
| POVIDONE, UNSPECIFIED(FZ989GH94E) | |
| propylene glycol(6DC9Q167V3) | |
| shellac(46N107B71O) | |
| sodium lauryl sulfate(368GB5141J) | |
| titanium dioxide(15FIX9V2JP) | |
| triacetin(XHX3C3X673) |
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