SPL Set ID: 604f663c-4933-402a-8105-5921713cf3c8

1 drug(s) with this SPL Set ID

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Eltrombopag olamine ELTROMBOPAG OLAMINE
12.5 mg Tablet
SOMERSET THERAPEUTICS, LLC FDA Rx Only

Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4- ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C 25 H 22 N 4 O 4 • 2(C 2 H 7 NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: microcrystaline cellulose, mannitol, povidone, isomalt, calcium silicate, sodium starch glycolate, and magnesium stearate. Coating: 12.5 mg: hypromellose 2910, titanium dioxide, triacetin. 25 mg: hypromellose 2910, titanium dioxide, triacetin, ferric oxide yellow, ferric oxide red. 50 mg: hypromellose 2910, titanium dioxide, triacetin, FD&C Blue No. 1/brilliant blue FCF aluminum lake, FD&C Blue No. 2/indigo carmine aluminum lake, ferrosoferric oxide. 75 mg: hypromellose 2910, titanium dioxide, triacetin, ferric oxide red. Image

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