mylan pharmaceuticals inc. - Medication Listings

Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula: Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake. Chlorthalidone Structural Formula

Cimetidine is a histamine H 2 -receptor antagonist. Chemically it is N" -cyano- N -methyl- N' -[2-[[(5-methyl-1 H -imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is: Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor. Solubility Characteristics Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Each tablet, for oral administration, contains 200 mg, 300 mg, 400 mg or 800 mg cimetidine, USP. Inactive ingredients are: croscarmellose sodium, crospovidone, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), sodium alginate, sodium lauryl sulfate, titanium dioxide, triacetin, vanillin, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Structural Formula

Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg – corn starch, FD & C blue no. 1, FD & C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium dioxide; 300 mg – corn starch, FD & C blue no. 1, gelatin, lactose, magnesium stearate, talc, and titanium dioxide. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside monohydrochloride. Chemical Structure

Clindamycin phosphate topical solution and clindamycin phosphate topical lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin phosphate topical gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. Each clindamycin phosphate topical solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, and water. The gel contains allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water. The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water. The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). Chemical Structure

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans- 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo- α− D-galacto -octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C 18 H 34 ClN 2 O 8 PS. The structural formula is represented below: Clindamycin phosphate vaginal cream 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, mixed fatty acid esters, mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, and stearic acid. Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. Chemical Structure

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, propylene glycol, potassium hydroxide, and purified water. Clindamycin Phosphate Structural Formula Benzoyl Peroxide Structural Formula

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) - 1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C 14 H 10 O 4 ). It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, propylene glycol, potassium hydroxide, and purified water. Clindamycin Phosphate Structural Formula Benzoyl Peroxide Structural Formula

Clonidine transdermal system, USP is a transdermal system providing continuous systemic delivery of clonidine for 7 days at an approximately constant rate. Clonidine is a centrally acting alpha-agonist hypotensive agent. It is an imidazoline derivative with the chemical name 2-[(2,6-Dichlorophenyl)imino]imidazolidine and has the following chemical structure: Meets USP Drug Release Test 3. System Structure and Components Clonidine transdermal system is a multi-layered film, 0.25 mm thick, containing clonidine as the active agent. The system areas are 3.33 cm 2 (0.1 mg/day), 6.67 cm 2 (0.2 mg/day), and 10.0 cm 2 (0.3 mg/day) and the amount of drug released is directly proportional to the area (see DESCRIPTION: Release Rate Concept ). The composition per unit area is the same for all three doses. Proceeding from the visible surface towards the surface attached to the skin, there are three consecutive layers: 1) a backing layer of pigmented polyethylene and polyester film, 2) a solid matrix reservoir of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide, 3) an adhesive formulation of clonidine, mineral oil, polyisobutylene, and colloidal silicon dioxide. Prior to use, a protective slit release liner of polyester that covers the adhesive formulation layer is removed. Clonidine transdermal systems are packaged with additional pieces of protective film above and below the system within each pouch. These pieces of protective film are removed and discarded at the time of use. Cross Section of the System: Clonidine Cross Section Release Rate Concept Clonidine transdermal system is programmed to release clonidine at an approximately constant rate for 7 days. The energy for drug release is derived from the concentration gradient existing between the patch and the much lower concentration prevailing in the skin. Clonidine flows in the direction of the lower concentration at a constant rate. Following system application to intact skin, clonidine in the adhesive formulation layer saturates the skin site below the system. Clonidine from the patch then begins to flow into the systemic circulation via the capillaries beneath the skin. Therapeutic plasma clonidine levels are achieved 2 to 3 days after initial application of clonidine transdermal system. The 3.33, 6.67, and 10.0 cm 2 systems deliver 0.1, 0.2, and 0.3 mg of clonidine per day, respectively. To ensure constant release of drug for 7 days, the total drug content of the system is higher than the total amount of drug delivered. Application of a new system to a fresh skin site at weekly intervals continuously maintains therapeutic plasma concentrations of clonidine. If the clonidine transdermal system is removed and not replaced with a new system, therapeutic plasma clonidine levels will persist for about 8 hours and then decline slowly over several days. Over this time period, blood pressure returns gradually to pretreatment levels. Clonidine Structural Formula

Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5 H -dibenzo [ b,e ] [1,4] diazepine. The structural formula is: Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. Clozapine ODT contains aspartame [see Warnings and Precautions (5.18) ] . Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine. structural formula

Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-Chloro-11-(4-methyl-1-piperazinyl)-5 H -dibenzo [ b,e ] [1,4] diazepine. The structural formula is: Clozapine is available in peach tablets of 25 mg or green tablets of 50 mg, 100 mg or 200 mg for oral administration. Active Ingredient: clozapine Inactive ingredients are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. In addition, the 25 mg tablets contain FD&C Red No. 40 Aluminum Lake, and the 50 mg, 100 mg and 200 mg tablets contain FD&C Blue No. 2 Aluminum Lake. Clozapine Structural Formula

Colchicine is an alkaloid chemically described as Acetamide, N -(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[ a ]heptalen-7-yl)-, (S)- with a molecular formula of C 22 H 25 NO 6 and a molecular weight of 399.44. The structural formula of colchicine is given below. Colchicine, USP occurs as a white to pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as red, film-coated, oval, scored tablets (0.1770” × 0.3240”), debossed with M on one side of the tablet and CC to the left of the score and 2 to the right of the score on the other side, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide. Colchicine Structural Formula

The active ingredient in colestipol hydrochloride tablets is micronized colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and 1-chloro-2, 3-epoxypropane, with approximately 1 out of 5 amine nitrogens protonated (chloride form). It is a light yellow water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids. Each colestipol hydrochloride tablet contains one gram of micronized colestipol hydrochloride. Colestipol hydrochloride tablets are light yellow in color and are tasteless and odorless. Inactive ingredients: cellulose acetate phthalate, glyceryl triacetate, carnauba wax, hypromellose, magnesium stearate, povidone, silicon dioxide. Colestipol hydrochloride tablets contain no calories.

Colestipol hydrochloride granules for oral suspension contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and 1-chloro-2, 3-epoxypropane, with approximately 1 out of 5 amine nitrogens protonated (chloride form). It is a light yellow water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids. Colestipol hydrochloride granules are tasteless and odorless. Inactive ingredient: silicon dioxide. One dose (1 packet or 1 level teaspoon) of colestipol hydrochloride granules contains 5 grams of colestipol hydrochloride.

Each 5 mL ampule of Cromolyn Sodium, USP contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium, USP Oral Concentrate is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Its chemical structure is: Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic Cromolyn Sodium Structural Formula

Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[( E )-(2 S ,3 R ,4 R )-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl-L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl] and it has the following structure: Structural Formula Formula: C 62 H 111 N 11 O 12 Mol. Wt.: 1202.6 Cyclosporine, USP is a white or almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine USP, 0.05%. Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Chemical Structure

CYSTAGON ® (cysteamine bitartrate) Capsules for oral administration, contain cysteamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON ® is the bitartrate salt of cysteamine, an aminothiol, beta-mercaptoethylamine. Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227 and the molecular formula C 2 H 7 NS • C 4 H 6 O 6 . It has the following chemical structure: Each CYSTAGON ® Capsule contains 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate. CYSTAGON ® Capsules contain the following inactive ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, propylene glycol, sodium lauryl sulfate and titanium dioxide. Cysteamine Bitartrate Structural Formula

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is Ethyl 3-{[(2-{[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1 H -benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoate, monomethanesulfonate. The empirical formula is C 34 H 41 N 7 O 5 •CH 4 O 3 S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is a white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, crospovidone, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain black iron oxide and red iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Dabigatran Etexilate Mesylate

Dapsone gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone gel, 7.5% is an off-white to yellow gel, smooth, homogenous and essentially free of foreign matter. Chemically, dapsone has an empirical formula of C 12 H 12 N 2 O 2 S. It is a white to creamy white, crystalline powder that has a molecular weight of 248.30. Dapsone’s chemical name is 4-[(4ʹ-aminobenzene) sulfonyl] aniline and its structural formula is: Each gram of dapsone gel, 7.5%, contains 75 mg of dapsone, USP, in a gel of diethylene glycol monoethyl ether, methylparaben, nitrogen, purified water and sepineo P 600 (which contains acrylamide/sodium acryloyldimethyl taurate copolymer, isohexadecane and polysorbate 80). Dapsone Structural Formula

DENAVIR (penciclovir) cream 1% contains penciclovir, an antiviral agent active against herpes viruses. DENAVIR is available for topical administration as a 1% white cream. Each gram of DENAVIR contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C 10 H 15 N 5 O 3 ; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure: Figure 1: Structural Formula of Penciclovir Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62). Penciclovir Structural Formula

Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen of 21 white to off-white round tablets each containing 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn- 4-en- 20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include anhydrous lactose, colloidal silicon dioxide, polyvinyl pyrrolidone, potato starch, stearic acid, and vitamin E, followed by 2 inert green round tablets with the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, ferric oxide yellow, lactose monohydrate, magnesium stearate and polacrilin potassium. Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP, 0.15 mg/0.02 mg and 0.01 mg also contain 5 light peach round tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20- yne-3,17-diol) and inactive ingredients which include anhydrous lactose, dl -alpha-tocopherol, FD&C Y ellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium and povidone K-25. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively. The structural formulas are as follows: Desogestrel and ethinyl estradiol tablets meet USP dissolution test 2 Desogestrel and Ethinyl Estradiol Structural Formulas

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is 2-[( R )-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2- pyridinyl]methyl]sulfinyl]-1 H -benzimidazole Sesquihydrate, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Dexlansoprazole sesquihydrate’s molecular formula is: C 16 H 14 F 3 N 3 O 2 S•1½ H 2 O, with a molecular weight of 396.39. Dexlansoprazole sesquihydrate has the following chemical structure: Dexlansoprazole sesquihydrate is a white to brown color powder which melts with decomposition at 85.5°C. Dexlansoprazole sesquihydrate is freely soluble in N,N-dimethylformamide and practically insoluble in water. Dexlansoprazole sesquihydrate is not stable when exposed to light. Dexlansoprazole sesquihydrate is not stable in alkaline or acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole sesquihydrate in a single type of enteric-coated pellets [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated pellets consisting of dexlansoprazole sesquihydrate (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose dispersion type B, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1) type A, mono- and di-glycerides, polysorbate 80, potassium hydroxide, povidone, sucrose, sugar spheres (corn starch and sucrose), talc and triethyl citrate. The components of the capsule shells include the following inactive ingredients: carrageenan, FD&C Blue No. 2, hypromellose, potassium chloride and titanium dioxide. The black imprinting ink contains black iron oxide, potassium hydroxide and shellac. Dexlansoprazole Structural Formula

Diazepam is a benzodiazepine derivative. The chemical name of diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, insoluble in water. The molecular formula is C 16 H 13 ClN 2 O and the molecular weight is 284.7. The structural formula is as follows: Diazepam is available for oral administration as tablets containing 2 mg, 5 mg or 10 mg diazepam, USP. In addition to the active ingredient diazepam, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 5 mg tablets also contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. structural formula

Diclofenac sodium/misoprostol is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium/misoprostol tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium/misoprostol 50) or 75 mg (diclofenac sodium/misoprostol 75) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are: C 14 H 10 Cl 2 NO 2 Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are: C 22 H 38 O 5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium/misoprostol include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate.

Difluprednate ophthalmic emulsion 0.05% is a sterile, white opaque to slightly translucent topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is 6α, 9-difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.56 g/mol, and the empirical formula is C 27 H 34 F 2 O 7 . Each mL of difluprednate ophthalmic emulsion contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%. Difluprednate Structural Formula

Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is (+)-5-[2-(Dimethylamino)ethyl]- cis -2,3-dihydro-3-hydroxy-2-( p -methoxyphenyl) -1,5-benzothiazepin-4(5 H )-one acetate (ester) monohydrochloride. The chemical structure is Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Each diltiazem hydrochloride extended-release capsule, USP contains either 60 mg diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem). Inactive ingredients: diethyl phthalate, FD&C Red No. 40, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer Type B, polyethylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres (corn starch and sucrose) and titanium dioxide. The 90 mg capsules also contain D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 4 . For oral administration. Diltiazem Hydrochloride Structural Formula

Each diphenoxylate hydrochloride and atropine sulfate tablet contains: 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine) Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of diphenoxylate hydrochloride and atropine sulfate tablets include acacia, corn starch, magnesium stearate, sorbitol, sucrose, and talc. Chemical Structure Chemical Structure

Disopyramide phosphate is an antiarrhythmic drug available for oral administration in immediate-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate is: α-[2-(diisopropylamino) ethyl]-α-phenyl- 2-pyridineacetamide phosphate Disopyramide phosphate is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/ml. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate is a racemic mixture of d- and l- isomers. This drug is not chemically related to other antiarrhythmic drugs. Inactive ingredients of disopyramide phosphate include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No. 1. Chemical Structure

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure: Divalproex sodium, USP occurs as a white crystalline powder with a characteristic odor. Divalproex sodium extended-release 250 and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 or 500 mg of valproic acid. Inactive Ingredients: ammonium hydroxide, colloidal anhydrous silica, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxyethyl cellulose, hypromellose, oleic acid, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide and triacetin. Meets USP Dissolution Test 3. Each 250 mg divalproex sodium extended-release tablet contains 20 mg of sodium. Each 500 mg divalproex sodium extended-release tablet contains 40 mg of sodium. Divalproex Structural Formula

Doxazosin is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of Doxazosin is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for Doxazosin is C 23 H 25 N 5 O 5 ∙ CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin tablet is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg orange tablet contains FD & C yellow 6; the 8 mg green tablet contains FD & C blue 2 and D & C yellow 10. Chemical Structure

Doxazosin is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of Doxazosin is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for Doxazosin is C 23 H 25 N 5 O 5 • CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin tablet is available as tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (white), 4 mg (white) and 8 mg (white) of doxazosin as the free base. The inactive ingredients for all tablets are lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate. Doxazosin Structural Formula

Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride is C 19 H 21 NO • HCl with a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in ethanol (96%), and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[ b , e ]oxepin-11(6 H )ylidene- N , N -dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride capsules are for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg and 100 mg of doxepin (equivalent to 11.4 mg, 28.5 mg, 57 mg, 85.5 mg and 114 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Doxepin Hydrochloride Structural Formula

Doxepin Hydrochloride Cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[ b,e ]oxepin-Δ11(6H),γ-propylamine hydrochloride. Doxepin hydrochloride has a molecular formula of C 19 H 21 NO•HCl and a molecular weight of 316. Doxepin Hydrochloride Cream, 5% also contains sorbitol, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, petrolatum, benzyl alcohol, titanium dioxide and purified water. Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[b,e]oxepin-Δ11(6H),γ-propylamine hydrochloride. Doxepin hydrochloride has an empirical formula of C19H21NO•HCl and a molecular weight of 316.

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are round, white to off-white, film-coated, delayed-release tablets containing 10 mg of doxylamine succinate and 10 mg of pyridoxine hydrochloride. Tablets are imprinted with M over DP in black ink on one side of the tablet and blank on the other side. Inactive ingredients are as follows: hypromellose, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol and talc. In addition, the black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Doxylamine Succinate: Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is 2-[α[2-(Dimethylamino)ethoxy]-α-methylbenzyl]pyridine succinate (1:1). The molecular formula is C 17 H 22 N 2 O • C 4 H 6 O 4 and the molecular mass is 388.46. The structural formula is: Doxylamine succinate, USP is a white or almost white powder, having a characteristic odor, that is very soluble in water and alcohol, freely soluble in chloroform and very slightly soluble in ether and benzene. Pyridoxine Hydrochloride: Pyridoxine hydrochloride is a vitamin B6 analog. The chemical name for pyridoxine hydrochloride is 3,4-Pyridinedimethanol, 5-hydroxy-6-methyl-, hydrochloride. The molecular formula is C 8 H 12 ClNO 3 and the molecular mass is 205.6. The structural formula is: Pyridoxine hydrochloride, USP is white or practically white crystals or crystalline powder that is freely soluble in water, slightly soluble in alcohol and insoluble in ether. Doxylamine Succinate Structural Formula Pyridoxine Hydrochloride Structural Formula

Drospirenone and ethinyl estradiol tablets USP, 3 mg/0.03 mg provide an oral contraceptive regimen consisting of 28 uncoated tablets that contain the ingredients specified for each tablet below: • 21 white to off-white tablets each containing 3 mg DRSP and 0.03 mg EE • 7 inert green tablets The inactive ingredients in the white to off-white tablets are corn starch, crospovidone, lactose monohydrate, magnesium stearate and povidone K-25. The green inert uncoated tablets contain FD & C Blue No. 1 Aluminium Lake, lactose monohydrate, magnesium stearate, polacrillin potassium and yellow iron oxide. Drospirenone (6 R ,7 R ,8 R ,9 S ,10 R ,13 S ,14 S ,15 S ,16 S ,17 S )-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a, 16-Hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16]cyclopenta[ a ] phenanthrene-17,2'(5 H )-furan]-3,5'(2 H )-dione) is a synthetic progestational compound and has a molecular weight of 366.49 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: Structural Formula

Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure: The molecular formula is C 22 H 26 N 2 O 2 S • HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Eletriptan Hydrobromide Structural Formula

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.25. It has the following structural formula: FTC is a white to off-white powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2-[[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl] adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P•C 4 H 4 O 4 and a molecular weight of 635.51. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strength: • Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. This strength of emtricitabine and tenofovir disoproxil fumarate tablets also includes the following inactive ingredients: croscarmellose sodium, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin and yellow iron oxide. Emtricitabine Structural Formula Tenofovir Disoproxil Fumarate Structural Formula

Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing FTC, rilpivirine hydrochloride, and TDF. Emtricitabine (FTC) is a synthetic nucleoside analog of cytidine. Rilpivirine (RPV) is a non-nucleoside reverse transcriptase inhibitor. Tenofovir disoproxil fumarate (TDF) is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 200 mg of FTC, 27.5 mg of rilpivirine hydrochloride (equivalent to 25 mg of RPV), and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, red iron oxide, talc, titanium dioxide, triacetin and yellow iron oxide. Emtricitabine: The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone. Emtricitabine is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.25. It has the following structural formula: FTC is a white to off-white powder with a solubility of approximately 112 mg per mL in water at 25°C. Rilpivirine : RPV is available as the hydrochloride salt. The chemical name for rilpivirine hydrochloride is 4-{[4-({4-[(E)-2-Cyanoethenyl]-2, 6-dimethylphenyl} amino) pyrimidin-2-yl] amino}benzonitrile. Hydrochloride. Its molecular formula is C 22 H 18 N 6 • HCl and its molecular weight is 402.9. Rilpivirine hydrochloride has the following structural formula: Rilpivirine hydrochloride is an off-white to yellow colored powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[2-(R)-[[bis[[(isopropoxy carbonyl) oxy] methoxy]phosphinoyl]methoxy]propyl]-adenine fumaric acid (1:1). It has a molecular formula of C 19 H 3 0N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.51. It has the following structural formula: TDF is a white to off-white powder with a solubility of 13.4 mg per mL in water at 25°C. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine Structural Formula Rilpivirine hydrochloride structural formula TDF structural formula

Eplerenone tablets contain eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C 24 H 30 O 6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below: Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: lactose, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium lauryl sulfate, talc, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, and iron oxide yellow and iron oxide red. Chemical Structure

Eplerenone tablets contain eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor. Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C 24 H 30 O 6 and it has a molecular weight of 414.50. The structural formula of eplerenone is represented below: Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0. Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, and yellow iron oxide. Structural Formula of Eplerenone

Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is The molecular formula of estradiol hemihydrate is C 18 H 24 O 2 • ½ H 2 O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. Estradiol Structural Formula Estradiol Transdermal System Three Layers

Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm 2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is: The molecular formula of estradiol hemihydrate is C 18 H 24 O 2 • ½ H 2 O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. Estradiol Structrual Formula Transdermal Patch Cross Section

Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm 2 ) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm 2 , and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. It has a molecular formula of C 18 H 24 O 2 • ½ H 2 O and molecular weight of 281.39. The structural formula is: Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: (1) A foam backing with adhesive layer (2) A polyester film (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive. Estradiol Structural Formula Transdermal Parts

Each gram of estradiol vaginal cream USP, 0.01% contains estradiol, USP hemihydrate equivalent to 0.1 mg estradiol in a nonliquefying base containing edetate disodium, hypromellose, methylparaben, mono- and di-glycerides, propylene glycol, purified water, sodium lauryl sulfate, stearyl alcohol, tert -butylhydroquinone and white ceresin wax. Estradiol is chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. It has an empirical formula of C 18 H 24 O 2 • ½ H 2 O and molecular weight of 281.39. The structural formula is: Estradiol Structural Formula

Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5 H -pyrrolo[3,4- b ] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its molecular formula is C 17 H 17 ClN 6 O 3 . Eszopiclone has a single chiral center with an ( S )-configuration. It has the following chemical structure: Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: black iron oxide, colloidal silicon dioxide, croscarmellose sodium type A, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide. Eszopiclone Structural Formula

Ethosuximide is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula: Each teaspoonful (5 mL), for oral administration, contains 250 mg ethosuximide, USP. Also contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No. 6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium benzoate, NF; sodium citrate, USP; sucrose, NF. Chemical Structure

Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg. Each light orange tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg package is a placebo containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor- 17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows: Therapeutic class: Oral contraceptive. Structure

Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/50 mcg. Each orange tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol, and the inactive ingredients include lactose monohydrate, povidone K-25, microcrystalline cellulose, polacrilin potassium, magnesium stearate. In addition, the coloring agent is FD&C Yellow No. 6 Aluminum Lake. Each green tablet in the ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/50 mcg package is an inert tablet containing no active ingredients, and the inactive ingredients include lactose monohydrate, polacrilin potassium, magnesium stearate, yellow iron oxide and FD&C Blue No. 1 Aluminum Lake. The chemical name for ethynodiol diacetate is 19-Nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol it is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. The structural formulas are as follows: Therapeutic class: Oral contraceptive. Structure Structure

Etoposide (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4’-Demethylepipodophyllotoxin 9-[4,6-O-( R )-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.56 and a molecular formula of C 29 H 32 O 13 . Etoposide may be administered either intravenously or orally. Etoposide capsules, USP are available as 50 mg opaque dark pink, oblong capsules. Each liquid filled, soft gelatin capsule contains 50 mg of etoposide, USP in a vehicle consisting of citric acid anhydrous, glycerol and polyethylene glycol. The soft gelatin capsules contain anidrisorb, gelatin and glycerol with the following dye system: red iron oxide and titanium dioxide; the capsules are printed with edible black ink containing FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose and propylene glycol. The structural formula is: Etoposide Structural Formula

EXEMESTANE tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C 20 H 24 O 2 and its structural formula is as follows: The active ingredient is a white to slightly yellow crystalline powder with a molecular weight of 296.41. Exemestane is freely soluble in N, N-dimethylformamide, soluble in methanol, and practically insoluble in water. Each EXEMESTANE tablet contains the following inactive ingredients: mannitol, crospovidone, polysorbate 80, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethylene glycol 6000, sucrose, magnesium carbonate, titanium dioxide, methylparaben, and polyvinyl alcohol. Chemical Structure

Felbamate is an antiepileptic available as 400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C 11 H 14 N 2 O 4 ; its structural formula is: The inactive ingredients for Felbamate Tablets, USP 400 mg and 600 mg are starch, microcrystalline cellulose, croscarmellose sodium, lactose, magnesium stearate, FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg tablets only). The inactive ingredients for Felbamate Oral Suspension, USP 600 mg/5 mL are sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharin sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water. Felbamate Structural Formula