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USFDA APPLICATION NUMBER - 21911 / DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| RUFINAMIDE(UNII: WFW942PR79) (RUFINAMIDE - UNII:WFW942PR79) | RUFINAMIDE | 200mg | 400mg | 40mg in 1 |
Inactive Ingredients
| Ingredient Name | Eisai Inc. |
|---|---|
| ANHYDROUS CITRIC ACID(XF417D3PSL) | |
| CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311) | |
| CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |
| CROSCARMELLOSE SODIUM(M28OL1HH48) | |
| DIMETHICONE(92RU3N3Y1O) | |
| FERRIC OXIDE RED(1K09F3G675) | |
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(S38J6RZN16) | |
| HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU) | |
| HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82) | |
| LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |
| MAGNESIUM STEARATE(70097M6I30) | |
| METHYLPARABEN(A2I8C7HI9T) | |
| ORANGE(5EVU04N5QU) | |
| POLOXAMER 188(LQA7B6G8JG) | |
| POLYETHYLENE GLYCOL 8000(Q662QK8M3B) | |
| POTASSIUM SORBATE(1VPU26JZZ4) | |
| PROPYLENE GLYCOL(6DC9Q167V3) | |
| PROPYLPARABEN(Z8IX2SC1OH) | |
| SILICON DIOXIDE(ETJ7Z6XBU4) | |
| SODIUM LAURYL SULFATE(368GB5141J) | |
| SORBITOL(506T60A25R) | |
| STARCH, CORN(O8232NY3SJ) | |
| TALC(7SEV7J4R1U) | |
| TITANIUM DIOXIDE(15FIX9V2JP) |
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