SPL Set ID: abea62b3-6a55-40a4-9e68-1ee9801e0f2c

1 drug(s) with this SPL Set ID

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Simpesse LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED FDA Rx Only

Simpesse (levonorgestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) is an extended-cycle oral contraceptive consisting of 84 white tablets each containing 0.15 mg of levonorgestrel USP, a synthetic progestogen and 0.03 mg of ethinyl estradiol USP, and 7 light blue tablets containing 0.01 mg of ethinyl estradiol USP. The structural formulas for the active components are: Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-­17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each white tablet contains the following inactive ingredients : croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Each light blue tablet contains the following inactive ingredients : colloidal silicon dioxide, FD&C Blue No. 1, lactose monohydrate, povidone, pregelatinized starch (maize), stearic acid, and vitamin E. Levonorgestrel Chemical Structure Ethinyl Estradiol Chemical Structure

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