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USFDA APPLICATION NUMBER - 21687 / DOSAGE - TABLET;ORAL - 10MG;80MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| EZETIMIBE(UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24) | EZETIMIBE | 10mg |
| SIMVASTATIN(UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) | SIMVASTATIN | 20mg |
Inactive Ingredients
| Ingredient Name | A-S Medication Solutions | Impax Generics | ANI Pharmaceuticals, Inc. | AvKARE | Lake Erie Medical DBA Quality Care Products LLC | Merck Sharp & Dohme Corp. | PD-Rx Pharmaceuticals, Inc. | REMEDYREPACK INC. |
|---|---|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | ||||||||
| ASCORBIC ACID(PQ6CK8PD0R) | ||||||||
| BUTYLATED HYDROXYANISOLE(REK4960K2U) | ||||||||
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | ||||||||
| citric acid monohydrate(2968PHW8QP) | ||||||||
| CROSCARMELLOSE SODIUM(M28OL1HH48) | ||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||||
| HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4) | ||||||||
| HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6) | ||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||
| ISOPROPYL ALCOHOL(ND2M416302) | ||||||||
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | ||||||||
| MAGNESIUM STEARATE(70097M6I30) | ||||||||
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | ||||||||
| POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | ||||||||
| PROPYL GALLATE(8D4SNN7V92) | ||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||
| TALC(7SEV7J4R1U) | ||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||
| WATER(059QF0KO0R) |
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