SPL Set ID: b4a200c1-f25a-4aa8-8770-06182fdeda9d

1 drug(s) with this SPL Set ID

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Dimethyl Fumarate DIMETHYL FUMARATE
120 mg Delayed-release
SOLA PHARMACEUTICALS, LLC FDA Rx Only

Dimethyl fumarate delayed-released capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ). It has the following structure: Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ethyl alcohol 96%, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methacrylic acid and methyl methacrylate copolymer (1:1), microcrystalline cellulose, purified water, talc, and triethyl citrate. The capsule shell, printed with black ink, contains the following inactive ingredients: FD&C Blue No. 1, gelatin, iron oxide black, iron oxide yellow, and titanium dioxide. 10

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