SPL Set ID: 71f90c73-63c2-432b-b112-cbdbd26b965c

1 drug(s) with this SPL Set ID

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Drospirenone and ethinyl estradiol DROSPIRENONE AND ETHINYL ESTRADIOL
CAMBER PHARMACEUTICALS, INC. FDA Rx Only

Drosperinone and ethinyl estradiol tablets USP provide an oral contraceptive regimen consisting of 24 pink active film-coated tablets each containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol and 4 white inert film coated tablets. The inactive ingredients in the pink tablets are corn starch, colloidal silicon dioxide, lactose monohydrate, macrogol/PEG, magnesium stearate, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, yellow iron oxide. The white inert film-coated tablets contain lactose monohydrate, macrogol/PEG, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S) 1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro­10,13-dimethylspiro-[17H dicyclopropa- [6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: Meets USP Dissolution Test 3. droseefigure3

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