Drugs Similar to HAILEY FE 1.5/30

Aurovela 24 Fe is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, and placebo tablets containing ferrous fumarate, which serve no therapeutic purpose. Each active light yellow to yellow tablet contains 1 mg norethindrone acetate USP and 20 mcg ethinyl estradiol USP. Inactive ingredients include compressible sugar, croscarmellose sodium, D & C Yellow No. 10 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and vitamin E. Each placebo brown tablet contains 75 mg ferrous fumarate, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Nat spearmint FL SD #11475, povidone and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The chemical name of ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The molecular formula of ethinyl estradiol is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate. The molecular formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is: Meets USP Dissolution Test 2. Structure-1 Structure-2

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

Aurovela Fe 1/20 is progestogen-estrogen combination. Aurovela Fe 1/20: 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 light yellow to yellow tablet contains norethindrone acetate USP (17 alpha-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol USP (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17 beta-diol), 20 mcg. Each light yellow to yellow tablet contains the following inactive ingredients: compressible sugar, croscarmellose sodium, D&C yellow No.10 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and vitamin E. 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. The structural formulas are as follows: Meets USP Dissolution Test 2 Chemical Structure Chemical Structure

Charlotte 24 Fe provides an oral contraceptive regimen consisting of 24 white to off-white active chewable tablets that contain the active ingredients, followed by 4 brown to dark brown non-hormonal placebo tablets as specified below: • 24 white to off-white, round, flat faced beveled edge, (active) chewable uncoated tablets debossed with “21” on one side and “Y” on the other side and each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. • 4 brown to dark brown, round, flat faced beveled edge, (non-hormonal placebo) uncoated tablets debossed with “18” on one side and “G” on the other side and each containing 75 mg ferrous fumarate, USP. Each white to off-white active chewable tablet also contains the following inactive ingredients: acacia, corn starch, lactose monohydrate, magnesium stearate, spearmint flavor, sucralose, sucrose and talc. Each brown to dark brown placebo tablet contains acacia, corn starch, ferrous fumarate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose and talc. The ferrous fumarate tablets, USP do not serve any therapeutic purpose. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol, USP is 296.40. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate, USP is 340.46. structure-1 structure-2

Finzala ® (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets) provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 24 white, round, flat-faced, beveled-edge, unscored tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. 4 brown, round, flat-faced, beveled-edge, unscored tablets each containing 75 mg ferrous fumarate, USP. Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, maltodextrin, pregelatinized corn starch, silicon dioxide, spearmint oil, sucralose, and talc. Each brown placebo tablet contains ferrous fumarate USP, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate type A, silicon dioxide, spearmint oil, and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The structural formula of ethinyl estradiol, USP is: C 20 H 24 O 2 MW: 296.40 The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The structural formula of norethindrone acetate, USP is: C 22 H 28 O 3 MW: 340.46 The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. FDA approved dissolution test specifications differ from USP. 1 1

Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Gemmily provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below: 24 oval, opaque, pale pink soft gelatin capsules each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate Each pink active capsule also contains the following inactive ingredients: sesame oil, linoleoyl polyoxylglycerides, DL-α-tocopherol, dehydrated alcohol, gelatin, sorbitol glycerin, FD&C Red #40, purified water, and titanium dioxide. Each maroon non-hormonal placebo capsule contains ferrous fumarate, soybean oil, lecithin, beeswax, gelatin, sorbitol, glycerin, FD&C Blue #1, FD&C Red #40, purified water, and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is: The following structural formula for The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17a)-]. The empirical formula of ethinyl estradiol is C20H24O2. The following structural formula for The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17a)-]. The empirical formula of norethindrone acetate is C22H28O3.

Hailey ® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, USP, a progestin, and ethinyl estradiol, USP, an estrogen, and placebo tablets containing ferrous fumarate, USP which serve no therapeutic purpose. • Each active white to off-white tablet contains 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. Inactive ingredients include acacia, corn starch, lactose monohydrate, magnesium stearate, sucrose and talc. • Each placebo brown to dark brown tablet contains 75 mg ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, corn starch and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: image-01 image-02

Hailey ® Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a progestogen-estrogen combination. Hailey Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP): 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 [(19-Norpregn-4-en-20-yn-3-one,17-(acetyloxy)-, (17α)], 1 mg; ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-], 20 mcg. Also contains acacia, lactose monohydrate, magnesium stearate, corn starch, sucrose and talc. The structural formulas are as follows: Norethindrone Acetate, USP Ethinyl Estradiol, USP Each brown to dark brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate, povidone, sodium starch glycolate, corn starch and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. NorStructure eestructure

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized starch. Each pink tablet contains norethindrone acetate (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. C22H28O3 M.W. 340.46 C20H24O2 M.W. 296.40 Norethindrone Acetate Structural Formula Ethinyl Estradiol Structural Formula

Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, USP, a progestin, and ethinyl estradiol, USP, an estrogen, and inert tablets containing ferrous fumarate, which serve no therapeutic purpose. Each active light yellow tablet contains 1 mg norethindrone acetate, USP and 0.02 mg ethinyl estradiol, USP. Each light yellow tablet also contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each inert brown tablet contains 75 mg ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The chemical name of ethinyl estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol, and the structural formula is: C 20 H 24 O 2 M.W. 296.40 The chemical name of norethindrone acetate, USP is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate, and the structural formula is: C 22 H 28 O 3 M.W. 340.46 ethinyl estradiol image norethindrone acetate image

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40

Loestrin ® 21 and Loestrin ® Fe 28 are progestogen-estrogen combinations. Loestrin ® Fe 1/20 and 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 light yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Melodetta™ 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. 4 brown, round tablets each containing 75 mg ferrous fumarate. Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. Each brown placebo tablet contains ferrous fumarate, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, spearmint flavor and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol, USP is 296.40. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate, USP is 340.46. chem structure chem structure 2

Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets USP provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: • 24 white to off-white, round, flat faced beveled edge, uncoated tablets debossed with “21” on one side and “Y” on the other side each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP • 4 brown to dark brown, round, flat faced beveled edge, uncoated tablets debossed with “18” on one side and “G” on the other side each containing 75 mg ferrous fumarate Each white active chewable tablet also contains the following inactive ingredients: acacia, corn starch, lactose monohydrate, magnesium stearate, spearmint flavor, sucralose, sucrose and talc. Each brown placebo tablet contains acacia, corn starch, ferrous fumarate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol, USP is 296.40. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate, USP is 340.46. EEstructure.jpg NEstructure.jpg

Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, USP a progestin, and ethinyl estradiol, USP an estrogen. Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below: • 24 oval, opaque, pale pink soft gelatin capsules each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. • 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate, USP. Each pink active capsule also contains the following inactive ingredients: sesame oil, corn oil PEG-6 esters, DL-α-tocopherol, dehydrated alcohol, bovine 150 bloom gelatin, sorbitol sorbitan solution, glycerin, FD&C Red #40, and titanium dioxide. Each maroon non-hormonal placebo capsule contains ferrous fumarate, soybean oil, soybean lecithin, yellow beeswax, bovine 150 bloom gelatin, sorbitol sorbitan solution, glycerin, FD&C Blue #1, FD&C Red #40 and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose. The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)]. The empirical formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is: ethinylestradiol norethindroneacetate