SPL Set ID: b31bd776-3926-4b77-aa29-f5a8eef611aa

1 drug(s) with this SPL Set ID

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Nylia 1/35 NORETHINDRONE AND ETHINYL ESTRADIOL
AUROBINDO PHARMA LIMITED FDA Rx Only

COMBINED ORAL CONTRACEPTIVES The following product is a combined oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. Nylia ® 1/35 Tablets: Each peach tablet contains 1 mg of norethindrone USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include anhydrous lactose, FD&C Yellow # 6 alumimum lake, lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Each green tablet contains only inert ingredients, as follows: anhydrous lactose, croscarmellose sodium, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone. The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, and for ethinyl estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulas are as follows: Meets USP dissolution test 3. Chemical Structure

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