SPL Set ID: db3d0229-4581-46c0-82a8-7d022c135826

1 drug(s) with this SPL Set ID

Open DailyMed details

AUROVELA Fe NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AUROBINDO PHARMA LIMITED FDA Rx Only

Aurovela Fe 1.5/30 is progestogen-estrogen combination. Aurovela Fe 1.5/30: Each provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off-white tablet contains norethindrone acetate USP (17 alpha-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol USP (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 30 mcg. Each white to off-white tablet contains the following inactive ingredients: compressible sugar, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and vitamin E. The structural formulas are as follows: Each brown placebo tablet contains the following ingredients: croscarmellose sodium, ferrous fumarate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Nat spearmint FL, povidone and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. Meets USP Dissolution Test 2. Chemical Structure1 Chemical Structure2

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