
USFDA APPLICATION NUMBER - 209410 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 258MG BASE
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| AMANTADINE(UNII: BF4C9Z1J53) (AMANTADINE - UNII:BF4C9Z1J53) | AMANTADINE | 161mg | 258mg | 129mg | 193mg |
Inactive Ingredients
| Ingredient Name | Vertical Pharmaceuticals, LLC |
|---|---|
| CELLULOSE ACETATE(3J2P07GVB6) | |
| COPOVIDONE K25-31(D9C330MD8B) | |
| D&C YELLOW NO. 10(35SW5USQ3G) | |
| FD&C BLUE NO. 1(H3R47K3TBD) | |
| FD&C BLUE NO. 2(L06K8R7DQK) | |
| FD&C RED NO. 40(WZB9127XOA) | |
| FD&C YELLOW NO. 6(H77VEI93A8) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| FERRIC OXIDE YELLOW(EX438O2MRT) | |
| FERROSOFERRIC OXIDE(XM0M87F357) | |
| HYPROMELLOSES(3NXW29V3WO) | |
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| MICROCRYSTALLINE CELLULOSE(OP1R32D61U) | |
| POLYETHYLENE GLYCOL 400(B697894SGQ) | |
| POLYSORBATE 80(6OZP39ZG8H) | |
| PROPYLENE GLYCOL(6DC9Q167V3) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| SODIUM CHLORIDE(451W47IQ8X) | |
| TITANIUM DIOXIDE(15FIX9V2JP) | |
| TRIACETIN(XHX3C3X673) |