SPL Set ID: 08f3a987-6571-42b3-854b-186d782b4494

1 drug(s) with this SPL Set ID

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Dimethyl Fumarate DIMETHYL FUMARATE
120 mg Delayed-release
AUROBINDO PHARMA LIMITED FDA Rx Only

Dimethyl fumarate delayed-release capsule contains 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 slightly soluble in methanol and highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate is 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, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion (which contains polymer substance based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), methacrylic acid copolymer Type A [which contains poly (methacrylic acid-co-methacrylate) 1:1 and sodium lauryl sulfate], silicified microcrystalline cellulose, talc and triethyl citrate. The empty hard gelatin capsule shell contains gelatin, sodium lauryl sulphate and titanium dioxide. In addition, the 240 mg capsule shell contains FD&C Blue 2 and iron oxide yellow. The capsules are imprinted with black edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. dimethyl-str

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