1H-1,2,3-Triazole-4-carboxamide, 1-((2,6-difluorophenyl)methyl)- | 201367 | SUSPENSION;ORAL | 40MG/ML

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SUSPENSION;ORAL - 40MG/ML, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 200MG, TABLET;ORAL - 400MG

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2 Rochem International Inc, 7 SPI Pharma, 11 DKSH, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 15 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 2 Finar, 6 Gangwal Chemicals, 4 Ideal Cures, 2 Ingredion Pharma Solutions, 19 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 24 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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USFDA APPLICATION NUMBER - 201367 / DOSAGE - SUSPENSION;ORAL - 40MG/ML

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.
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)

Setid 0a3fa925 1abd 458a Bd57 4ae780a1ef2d Applno 201367 Form Suspension Oral Dosage 40mg Ml - Drug Product Composition: 1H-1,2,3-Triazole-4-carboxamide, 1-((2,6-difluorophenyl)methyl)-