1H-1,2,3-Triazole-4-carboxamide, 1-((2,6-difluorophenyl)methyl)-

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SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG

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USFDA APPLICATION NUMBER - 21911 / DOSAGE - TABLET;ORAL - 200MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RUFINAMIDE(UNII: WFW942PR79) (RUFINAMIDE - UNII:WFW942PR79)	RUFINAMIDE	200mg \| 400mg \| 40mg in 1

Inactive Ingredients

Ingredient Name	Eisai Inc.	Glenmark Pharmaceuticals Inc., USA	Lupin Pharmaceuticals, 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)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
ORANGE(5EVU04N5QU)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
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)

Setid 0a3fa925 1abd 458a Bd57 4ae780a1ef2d Applno 21911 Form Tablet Oral Dosage 200mg - Drug Product Composition: 1H-1,2,3-Triazole-4-carboxamide, 1-((2,6-difluorophenyl)methyl)-