zydus pharmaceuticals usa inc. - Medication Listings

Bromocriptine mesylate is an ergot derivative with potent dopamine receptor agonist activity. Bromocriptine mesylate is chemically designated as Ergotaman-3΄, 6΄, 18-trione, 2-bromo-12΄-hydroxy-2΄-(1-methylethyl)-5΄-(2-methylpropyl)-, (5΄α)-mono-methanesulfonate (salt). The structural formula is: C 32 H 40 BrN 5 O 5 .CH 4 SO 3 Mol. wt. 750.70 Bromocriptine mesylate, USP is white or slightly colored, fine crystalline powder and odorless or having a weak, characteristic odor. Each bromocriptine mesylate capsule USP, 5 mg intended for oral administration contains bromocriptine mesylate equivalent to 5 mg of bromocriptine. In addition, each capsule contains the following inactive ingredients: carrageenan, colloidal silicon dioxide, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, maleic acid, potassium hydroxide and titanium dioxide. Each capsule is printed with black pharmaceutical ink and has following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. 5 mg

Budesonide USP, the active ingredient of budesonide delayed-release capsules, is a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17, 21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide, USP is a white to off-white, odorless, crystalline powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 10 3 ionic strength 0.01. Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: acetyltributyl citrate, ethylcellulose aqueous dispersion, gelatin, iron oxide red, iron oxide yellow, methacrylic acid copolymer dispersion, polysorbate 80, simethicone emulsion, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsule shell is printed with black pharmaceutical ink which contains following ingredients: iron oxide black, potassium hydroxide, propylene glycol and shellac. budesonide

Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula: Each bumetanide tablet intended for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition, each 0.5 mg tablet contains D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake and ferric oxide black; each 1 mg tablet contains D&C Yellow No. 10 aluminum lake and ferric oxide red; each 2 mg tablet contains mg D&C Yellow No. 10 aluminum lake and ferric oxide red. Bumetanide tablet meets USP Dissolution Test 2. figure 1

Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2•HCl is represented by the following structural formula: Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 7.5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 6.85 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Structural formula

Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H -dibenz[ b , f ]azepine-5-carboxamide, and its structural formula is: Carbamazepine USP is a white to off-white odourless crystalline powder, sparingly soluble in acetone and in ethanol (96%), very slightly soluble in water. Its molecular weight is 236.27. Each carbamazepine extended-release tablet, USP intended for oral administration contains 100 mg, 200 mg and 400 mg of carbamazepine. In addition, each tablet contains the following inactive ingredients: cellulose acetate, dextrates, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, polyethylene glycol and sodium lauryl sulfate. Each tablet is printed with opacode black S-1-17823 ink which contains ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. Meets USP Dissolution Test 2. figure

Carbidopa, USP is an inhibitor of aromatic amino acid decarboxylation. It is white to creamy white powder, freely soluble in 3N hydrochloric acid, slightly soluble in water and methanol, practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.24. It is designated chemically as (–)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10 H 14 N 2 O 4 •H 2 O and its structural formula is: Carbidopa tablets contain 25 mg of carbidopa, USP. Inactive ingredients are crospovidone type B, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, magnesium stearate, mannitol and microcrystalline cellulose. Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. Carbidopa Tablets, USP

Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C 10 H 14 N 2 O 4 • H 2 O and its structural formula is: Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C 9 H 11 NO 4 and its structural formula is: Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain gelatin and titanium dioxide. In addition, all blue capsule shells contain FD&C Blue #2 and yellow iron oxide. All yellow capsule shells contain yellow iron oxide. All capsules imprinted with blue pharmaceutical ink contain FD&C Blue #2, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac and strong ammonia solution. Image Image

The active ingredient in carmustine for injection, USP is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for injection, USP is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine is: Carmustine for injection, USP is available in 100-mg single dose vials of lyophilized material. Sterile diluent for constitution of carmustine for injection, USP is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP. Image

Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula: Chlorpromazine hydrochloride, USP occurs as white to almost white crystalline powder. Each film coated tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: Calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Image

Chlorpromazine hydrochloride, USP is chemically designated as 2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine monohydrochloride and has the following structural formula: C 17 H 19 ClN 2 S • HCl MW 355.33 g/mol Chlorpromazine hydrochloride injection, USP is a sterile aqueous clear colorless to yellow color solution intended for deep intramuscular use. Each mL contains chlorpromazine hydrochloride 25 mg, ascorbic acid 2 mg, sodium metabisulfite 1 mg, sodium sulfite 1 mg and sodium chloride 6 mg in Water for Injection. pH is 3.4 to 5.4. Image

Chlorthalidone is 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: Molecular Formula : C 14 H 11 ClN 2 O 4 S Molecular weight: 338.76 Chlorthalidone, USP is white to yellowish-white, crystalline powder that melts at a temperature 216°C to 222°C, with decomposition. It is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in alcohol. Chlorthalidone tablets, USP are available containing either 25 mg or 50 mg of chlorthalidone USP and the following inactive ingredients: colloidal silicon dioxide, corn starch,microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid.Additionally 25 mg tablet contain ferric oxide yellow. Chlorthalidone tablets, USP

Cholestyramine for oral suspension USP light powder, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in cholestyramine for oral suspension USP light powder is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 5.5 grams of cholestyramine for oral suspension USP light powder. It is represented by the following structural formula: Cholestyramine for oral suspension USP light powder contains the following inactive ingredients: aspartame, citric acid, colloidal silicon dioxide, D&C Yellow # 10 aluminum lake, FD&C Yellow # 6 aluminum lake, flavor (natural and artificial Orange, natural and artificial Vanilla), mannitol, propylene glycol alginate and xanthan gum. Formula

Cholestyramine for oral suspension USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in cholestyramine for oral suspension, USP is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of cholestyramine for oral suspension, USP. It is represented by the following structural formula: Cholestyramine for oral suspension, USP contains the following inactive ingredients: citric acid, d & c yellow # 10 aluminum lake, flavor (natural and artificial orange, natural and artificial vanilla), fd & c yellow # 6 aluminum lake, propylene glycol alginate, sucrose and xanthan gum. Formula

Cisatracurium besylate injection USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate USP is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate USP is [1 R -[1α,2α(1' R *,2' R *)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C 53 H 72 N 2 O 12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C 65 H 82 N 2 O 18 S 2 and the molecular weight is 1243.49. The structural formula of cisatracurium besylate USP is: The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. The pH of cisatracurium besylate injection, USP is between 3.25 and 3.65. Image

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to off white gel formulation. Clindamycin phosphate, USP 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. Clindamycin phosphate, USP is C 18 H 34 ClN 2 O 8 PS and is a white or almost white, hygroscopic crystalline powder and soluble in water, practically insoluble in dichloromethane, chloroform, benzene and ether. The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate has a molecular weight of 504.96 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 - D-D- galacto -octopyranoside 2-(dihydrogen phosphate). Benzoyl peroxide, USP is C 14 H 10 O 4 . It has the following structural formula: Hydrous benzoyl peroxide, USP has a molecular weight of 242.23. It is white or almost white amorphous or granular powder and practically insoluble in water, slightly soluble in alcohol, soluble in acetone, in chloroform, in dichloromethane and in ether with separation of water Each gram of clindamycin phosphate and benzoyl peroxide gel contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, disodium lauryl sulfosuccinate, edetate disodium, glycerin, methylparaben, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide. Image Image

Clobetasol propionate ointment USP, 0.05% contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream crystalline powder and soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane; sparingly soluble in ethanol; slightly soluble in benzene and diethyl ether and practically insoluble in water. Clobetasol propionate ointment USP, 0.05% is translucent ointment, contains clobetasol propionate, USP 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. Image

Clobetasol propionate spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17 dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C 25 H 32 CIFO 5 , and a molecular weight of 466.97 (CAS Registry Number 25122-41-2). The following is the chemical structure: Clobetasol propionate, USP is a white to cream crystalline powder that is soluble in acetone, in dimethyl sulfoxide, in chloroform, in methanol, and in dioxane; sparingly soluble in ethanol; slightly soluble in benzene and in diethyl ether; and practically insoluble in water. Each gram of clobetasol propionate spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid. Clobetasol Propionate Spray

Colchicine is an alkaloid chemically described as (S)N- (5,6,7,9-tetrahydro- 1,2,3, 10-tetramethoxy-9-oxobenzo [alpha] heptalen-7-yl) acetamide with a molecular formula of C 22 H 25 NO 6 and a molecular weight of 399.4. The structural formula of colchicine is given below. Colchicine, USP is white to pale yellow powder. It is very soluble in water, freely soluble in alcohol and chloroform, slightly soluble in ether and practically insoluble in cyclohexane. Each colchicine tablet, USP contains 0.3 mg or 0.6 mg colchicine and contains following inactive ingredients: carmine, FD&C blue #2, ferrosoferric oxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. Image

Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula: wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets). Image

The active ingredient in colestipol hydrochloride tablets is 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-epoxpropane (hydrochloride), with approximately one out of five amine nitrogens protonated. It is a yellow to orange powder or beads water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids. Each colestipol hydrochloride tablet contains one gram of colestipol hydrochloride. Colestipol hydrochloride tablets are light yellow to yellow in color and are tasteless and odorless. Inactive ingredients: cellacefate, colloidal silicon dioxide, crospovidone, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, and triacetin.

Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride USP, 0.9%. Benzyl Alcohol NF, 1.5%, is present as a preservative. Dibasic Sodium Phosphate (Heptahydrate) USP 0.05% is present as a buffering agent. Hydrochloric acid NF and/or sodium hydroxide NF may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as crystals or deep red colored, odorless crystalline powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.35%. The molecular weight is 1355.4. The structural formula is represented below. Image

Cyproheptadine hydrochloride, USP is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride, USP is a white to slightly yellow, odorless or practically odorless, crystalline powder, with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, soluble in chloroform, sparingly soluble in alcohol, practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo [a, d] cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C 21 H 21 N•HCl and the structural formula of the anhydrous salt is: Molecular Formula: C 21 H 21 N• HCl Molecular Weight: 350.89 Cyproheptadine hydrochloride, USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate (botanical source: potato). Cyproheptadine HCl tablet

Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22 H 26 ClN 7 O 2 S • H 2 O, which corresponds to a molecular weight of 506.02 g/mol (monohydrate). The anhydrous free base has a molecular weight of 488.01 g/mol. Dasatinib has the following chemical structure: Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Each dasatinib tablet intended for oral administration contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg of dasatinib. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, glyceryl monocaprylocaprate type 1, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, sodium lauryl sulfate, talc and titanium dioxide. Image

Deferasirox is an iron-chelating agent provided as a tablet for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid and has the following structural formula: Deferasirox is a white to slightly yellow color powder. It has a molecular formula C 21 H 15 N 3 O 4 and molecular weight of 373.36 g/mol. It is freely soluble in dimethyl formamide, sparingly soluble in dimethylsulfoxide and practically insoluble in water with a pH of suspension of 4.1. Each deferasirox tablet contains 90 mg, 180 mg or 360 mg deferasirox and contains following Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, povidone K30, poloxamer 407, talc and titanium dioxide. Additionally, each 180 mg and 360 mg tablet contains FD&C blue # 2/Indigo Carmine Aluminum Lake; each 180 mg tablet contains iron oxide yellow and each 360 mg tablets contain D&C red #27/Phloxine Aluminum Lake. Image

The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25 H 31 NO 6 . The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is: Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. Image

The active ingredient in deflazacort oral suspension is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25 H 31 NO 6 . The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structure is: Deflazacort is a white to off white fine powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and soluble in methanol and acetone. Deflazacort for oral administration is available as an immediate-release oral suspension in a strength of 22.75 mg/mL. The oral suspension contains deflazacort and the following inactive ingredients: benzyl alcohol, carboxymethylcellulose sodium, glacial acetic acid, magnesium aluminum silicate, polysorbate 80, purified water and sorbitol solution. Image

Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, benzoic acid, benzyl alcohol (1.5%), ethyl alcohol (10%), hydroxypropyl methylcellulose, propylene glycol, purified water, and sodium benzoate. Diazepam rectal gel is clear, colorless to yellow and has a pH between 6.5-7.2. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one. The structural formula is as follows: Image

Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as immediate-release tablets of 50 mg (white to off-white) for oral administration. Diclofenac potassium, USP is a White to off-white or slightly yellowish crystalline powder, slightly hygroscopic and is freely soluble in methanol; soluble in alcohol; sparingly soluble in water; slightly soluble in acetone. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14 H 10 Cl 2 NKO 2 , and it has the following structural formula. The inactive ingredients in diclofenac potassium tablets include: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate, hypromellose, talc & titanium dioxide. diclofenac potassium

Diflunisal is 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid. Its structural formula is: C 13 H 8 F 2 O 3 M.W. 250.20 Diflunisal is a stable, white to off-white, crystalline compound with a melting point of 211° to 213°C. It is practically insoluble in hexane and water. It is soluble in most organic solvents including acetone and ethyl acetate and it is slightly soluble in chloroform, carbon tetrachloride and methylene chloride. Each diflunisal tablet intended for oral administration contains 500 mg of diflunisal. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, microcrystalline cellulose, pregelatinised starch and sodium stearyl fumarate. Additionally, each diflunisal tablets contain opadry blue 03B505010 which contains FD&C blue #2, FD&C yellow #6, hypromellose, polyethylene glycol and titanium dioxide. Structure

Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is: Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsule, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). Each capsule contains the following inactive ingredients: acetyl tributyl citrate, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, colloidal silicon dioxide, gelatin, hypromellose, sodium lauryl sulfate, sugar sphere, talc and titanium dioxide. Additionally each 120 mg capsule shell contains D & C yellow # 10, FD & C blue # 1 and FD & C red # 40; each 180 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and iron oxide black; each 240 mg capsule shell contains FD & C blue # 1 and FD & C red # 3; each 300 mg capsule shell contains D & C yellow # 10, FD & C blue # 1, FD & C red # 40 and iron oxide black; each 360 mg capsule shell contains iron oxide black. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Diltiazem Hydrochloride Extended-release Capsule, USP meets USP Dissolution Test 3. For oral administration. figure

Dimethyl fumarate delayed-release capsules contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ). It has the following structure: Dimethyl fumarate is a white to off-white powder that is soluble in methanol and slightly soluble in water with a molecular mass of 144.13. Each dimethyl fumarate delayed-release capsule intended for oral administration contains 120 mg or 240 mg dimethyl fumarate respectively and contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, microcrystalline cellulose, magnesium stearate, methacrylic acid copolymer (Type A), methacrylic acid copolymer dispersion (Type C), mono and di-glycerides, povidone, polysorbate 80, sodium lauryl sulphate, talc and triethyl citrate. The capsule shell contains following inactive ingredients: D&C Yellow#10, FD&C Blue#1, FD&C Red#40, gelatin and titanium dioxide. The capsule shell is imprinted with black pharmaceutical ink and contains the following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Image

Dipyridamole is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4- d ]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula: C 24 H 40 N 8 O 4 Mol. Wt. 504.63 Dipyridamole, USP is intensely yellow crystalline powder or needles. It is very soluble in methanol, in alcohol, and in chloroform; slightly soluble in water; very slightly soluble in acetone and in ethyl acetate. Each dipyridamole tablet intended for oral administration contains 25 mg or 50 mg or 75 mg of dipyridamole. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. structured formula for dipyridamole

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure: Divalproex sodium, USP occurs as a white powder with a characteristic odor. Each divalproex sodium delayed-release capsules, USP intended for oral administration contains divalproex sodium equivalent to 125 mg of valproic acid. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, FD &C blue # 1, gelatin, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose spheres, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. Each capsule is printed with black pharmaceutical ink which contains: ammonia solution, butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water and shellac. The Product meets USP Dissolution Test 4. Structured product formula for Divalproex

Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4 benzodioxan-2-ylcarbonyl)piperazine methanesulfonate. The empirical formula for doxazosin mesylate 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 mesylate, USP is white to off white powder. It is freely soluble in formic acid; very slightly soluble in methanol and in water. Doxazosin is available as tablets for oral use and contains 1 mg (white), 2 mg (pink), 4 mg (pink) and 8 mg (purple) of doxazosin as the free base. Each doxazosin tablet, USP for oral administration contains 1 mg or 2 mg or 4 mg or 8 mg of doxazosin as 1.213 mg or 2.426 mg or 4.852 mg or 9.703 mg of doxazosin mesylate, respectively and inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (botanical source: potato) and sodium lauryl sulphate. Additionally 8 mg tablet contains FD&C red #40 aluminum lake, FD&C blue #2 aluminum lake and 2 mg and 4 mg tablet contains ferric oxide red. Doxazosin Tablets, USP

Doxorubicin hydrochloride liposome injection is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in pegylated liposomes for intravenous use. The chemical name of doxorubicin hydrochloride is (8S,10S)-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycolyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The molecular formula is C 27 H 29 NO 11 ∙HCl and the molecular weight is 579.99. The structural formula is: Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion. Each single-dose vial contains 20 mg or 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL (equivalent to 1.87 mg/mL of doxorubicin). The pegylated liposome carriers are composed of cholesterol, 3.19 mg/mL; fully hydrogenated soy phosphatidylcholine (HSPC), 9.58 mg/mL; and N-(carbonyl-methoxypolyethylene glycol 2,000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt (MPEG-DSPE), 3.19 mg/mL. Each mL also contains ammonium sulfate, approximately 0.6 mg; histidine 1.50 mg as a buffer; hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (6.0 to 7.0); and sucrose, 95.50 mg to maintain isotonicity. Greater than 90% of the drug is encapsulated in the pegylated liposomes. MPEG-DSPE has the following structural formula: HSPC has the following structural formula: Representation of a pegylated liposome: Image Image Image Image

Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline tablets USP, 50 mg, 75 mg, 100 mg and 150 mg contain doxycycline monohydrate equivalent to 50 mg, 75 mg, 100 mg or 150 mg of doxycycline, USP for oral administration. Doxycycline, USP is light yellow to pale yellow powder, very slightly soluble in alcohol and water; practically insoluble in ether. It dissolves in dilute solutions of mineral acids and in solutions of alkali hydroxides and carbonates. Its molecular weight is 462.45. The chemical designation of doxycycline is alpha-6-deoxy-5-oxytetracycline. Structural formula: Image C 22 H 24 N 2 O 8 •H 2 O M.W. = 462.45 Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients are as follows: colloidal silicon dioxide, crospovidone, hydroxyl propyl methylcellulose, magnesium stearate and microcrystalline cellulose, titanium dioxide. In addition, 50 mg tablets contain: D&C yellow#10 aluminum lake, FD&C blue#2, iron oxide yellow, polyethylene glycol and polysorbate 80. 75 mg tablets contain: iron oxide red, iron oxide yellow, lactose monohydrate, triethyl citrate. 100 mg tablets contain: D&C yellow#10 aluminum lake, FD&C red#40, iron oxide yellow, polyethylene glycol, polysorbate 80. 150 mg tablets contain: D&C yellow#10 aluminum lake, iron oxide red, iron oxide yellow, lactose monohydrate, triethyl citrate. The Product meets USP dissolution test - 2 Structural formula

Doxycycline is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain doxycycline monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow to pale yellow powder is alpha-6-deoxy-5-oxytetracycline. Structural formula: C 22 H 24 N 2 O 8 • H 2 O M.W. = 462.45 Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each doxycycline capsule, USP intended for oral administration contains 50 mg or 75 mg or 100 mg of doxycycline. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. Additionally, each 50 and 100 mg capsule shell contains iron oxide yellow, each 75 mg and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1, FD & C red # 3 and FD & C yellow # 6 and each 100 mg capsule shell contains iron oxide red. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The Product meets USP Dissolution Test 2. Aripiprazole Tablets

Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is meant for INTRAVENOUS use only after reconstitution. Doxycycline hyclate is a yellow to light yellow powder which is chemically designated 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11- dioxo-2-naphthacenecarboxamide, monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. It has the following structural formula: Doxycycline hyclate is soluble in water and chars at 201°C without melting. The base doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg doxycycline; ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3. Each 200 mg vial contains: Doxycycline hyclate equivalent to doxycycline 200 mg; ascorbic acid 960 mg; mannitol 600 mg. pH of the reconstituted solution (10 mg/mL) is between 1.8 and 3.3. Image

Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is white to light brown color powder. It is soluble in 1 N hydrochloric acid, slightly soluble in water and practically insoluble in ethanol (99.5 %). It has a molecular weight of 213.19 and a molecular formula of C 9 H 11 NO 5 . Droxidopa Capsules, 100 mg, 200 mg and 300 mg intended for oral administration contain 100 mg, 200 mg and 300 mg droxidopa and contains the following inactive ingredients: corn starch (botanical source: maize), mannitol, magnesium stearate and sodium lauryl sulphate. Each hard gelatin capsule shell contains gelatin, titanium dioxide and water. Additionally, each 100 mg capsule shell contains: FD&C blue #1 and FD&C Red#40; each 200 mg capsule shell contains: iron oxide black, iron oxide red and iron oxide yellow; and each 300 mg capsule shell contains FD&C blue #1 and iron oxide yellow. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients:, black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Image

Dutasteride and tamsulosin hydrochloride capsules contain dutasteride (a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT and tamsulosin (an antagonist of alpha1A-adrenoceptors in the prostate). Each dutasteride and tamsulosin hydrochloride capsule contains the following: One dutasteride opaque white colored, oblong shaped soft gelatin capsules containing clear colorless to slightly yellowish oily liquid, containing 0.5 mg dutasteride and the inactive ingredients: butylated hydroxy toluene, gelatin, glycerin, methylparaben, mono and diglycerides of capric acid, propylparaben and titanium dioxide. Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin hydrochloride and the inactive ingredients: microcrystalline cellulose, methacrylic acid copolymer dispersion, talc and triacetin. The above components are encapsulated in a hard-shell capsule made with the inactive ingredients: carrageenan, hypromellose, iron oxide yellow, potassium chloride, titanium dioxide, and imprinted with black pharmaceutical ink which contains butyl alcohol, ferrosoferic oxide, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution. Dutasteride: Dutasteride, USP is a synthetic 4-azasteroid compound chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The molecular formula of dutasteride is C 27 H 30 F 6 N 2 O 2 , representing a molecular weight of 528.5 with the following structural formula: Dutasteride, USP is white to off-white colored powder. It is soluble in absolute ethanol and methanol and insoluble in water. Tamsulosin: Tamsulosin hydrochloride, USP is a synthetic compound chemically designated as (-)-( R )-5-[2-[[2-( o -Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. The molecular formula of tamsulosin hydrochloride is C 20 H 28 N 2 O 5 S•HCl. The molecular weight of tamsulosin hydrochloride is 444.97. Its structural formula is: Tamsulosin hydrochloride, USP is white crystalline powder, odorless or practically odorless. It is slightly soluble in water and anhydrous ethanol, sparingly soluble in methanol, freely soluble in dimethyl sulfoxide and formic acid, practically soluble in ether. Dutasteride and tamsulosin hydrochloride capsules Dutasteride and tamsulosin hydrochloride capsules

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 a white to off white solid that is slightly soluble in water. Each eletriptan hydrobromide Tablet for oral administration contains 24.25 or 48.5 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, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, titanium dioxide and triacetin. Additionally, each 20 mg tablet contains D & C Yellow #10 aluminum lake and FD & C Blue #2 aluminum lake and each 40 mg tablet contains ferric oxide yellow and ferric oxide red. eletriptan hydrobromide tablet

Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25 H 22 N 4 O 4 .2(C 2 H 7 NO). The molecular weight is 564.64 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.5, very slightly soluble in water, slightly soluble in methanol and ethanol. Each film-coated tablets contain eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid and contains the following inactive ingredients: hypromellose, microcrystalline cellulose, polyethylene glycol, povidone (k-30), sodium starch glycolate, sodium stearyl fumarate, titanium dioxide and xylitol. Additionally, each 25 mg tablet contains iron oxide red and iron oxide yellow, each 50 mg tablet contains FD&C blue #2 Aluminum Lake and each 75 mg tablet contains ferrosoferric oxide and iron oxide red. Image

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (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, USP The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. 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 247.30. It has the following structural formula: FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. 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 635.52. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. 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 strengths: 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 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients Each emtricitabine and tenofovir disoproxil fumarate film-coated tablet contains following inactive ingredients: croscarmellose sodium, glyceryl monocaprylocaprate type I, hypromellose, kaolin, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch (maize), sodium lauryl sulfate, sodium stearyl fumarate and titanium dioxide. Image Image

Enoxaparin Sodium Injection USP is a sterile aqueous solution containing enoxaparin sodium, USP, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium, USP is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is: <2000 daltons ≤20% 2000 to 8000 daltons ≥68% >8000 daltons ≤18% STRUCTURAL FORMULA * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection USP, 100 mg/mL Concentration contains 10 mg enoxaparin sodium, USP (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection USP, 150 mg/mL Concentration contains 15 mg enoxaparin sodium, USP (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration ( 2 ) and How Supplied/Storage and Handling ( 16 )] . Structural Formula Structural Formula 2

Entecavir is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one, monohydrate. Its molecular formula is C 12 H 15 N 5 O 3 •H 2 O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula: Entecavir, USP is a white to off-white crystalline powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C. Entecavir tablets, USP are available as film-coated tablets for oral administration. Each tablet contains 0.5 mg or 1 mg Entecavir, USP and following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet coating contains hypromellose, polyethylene glycol, talc, and titanium dioxide, and additionally 1 mg tablet contains iron oxide red and iron oxide yellow. Entecavir

Erlotinib tablet, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy) -4-quinazolinamine hydrochloride. Erlotinib tablet contains erlotinib as the hydrochloride salt that has the following structural formula: Erlotinib hydrochloride has the molecular formula C 22 H 23 N 3 O 4 •HCl and a molecular weight of 429.90. The molecule has a pKa of 5.35 at 25°C. Erlotinib hydrochloride is off white to pale yellow powder. It is slightly soluble in methanol and practically insoluble in acetonitrile and acetone. Aqueous solubility of erlotinib hydrochloride at 25˚C is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.2 to 9.5, maximal solubility of approximately 0.15 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide. Image

Erythromycin tablets, USP are an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white or slightly yellow powder or colorless or slightly yellow crystals, very slightly soluble to practically insoluble in water and soluble in alcohol, in chloroform and in ether. Erythromycin is known chemically as (3 R *,4 S *,5 S *,6 R *,7 R *,9 R *,11 R *,12 R *,13 S *,14 R *)-4-[(2,6-Dideoxy-3- C -methyl-3- O -methyl-α- L -ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β- D -xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37 H 67 NO 13 and the molecular weight is 733.93. The structural formula is: Inactive Ingredients Colloidal silicon dioxide, crospovidone, croscarmellose sodium, D&C red #30 aluminium lake, hydroxypropyl cellulose, hypromellose phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone (k-30), povidone (k-90), propylene glycol, sodium citrate dihydrate, sorbic acid, sodium hydroxide, sorbitan monooleate, titanium dioxide and talc. Additionally, each 250 mg tablets contain iron oxide yellow. Image

Estradiol Transdermal System, USP is designed to release estradiol continuously upon application to intact skin. Six (7.5, 11.25, 15, 18, 22.5 and 30 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 7.5, 11.25, 15, 18, 22.5 or 30 cm 2 , and contains 1.888, 2.832, 3.777, 4.532, 5.665 or 7.553 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white or creamy white, small crystals or crystalline powder, odorless, stable in air and hygroscopic. Estradiol USP is chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The Estradiol Transdermal System, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: A translucent polyethylene film. An acrylate adhesive matrix containing estradiol USP. A protective liner of silicone coated polyester film is attached to the adhesive surface and must be removed before the system can be used. Cross Section of the System Estradiol Transdermal System, USP is packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use. The active component of the system is estradiol USP. The remaining components of the system (acrylic adhesive, colloidal silicon dioxide, ethyl oleate, glyceryl monolaurate, isopropyl myristate, povidone and polyethylene backing) are pharmacologically inactive. FDA approved drug release test specifications differ from USP. Estradiol Transdermal System Estradiol Transdermal System

Estradiol transdermal system, USP is designed to provide nominal in vivo delivery of 0.014 mg of estradiol per day continuously upon application to intact skin. The period of use is 7 days. The transdermal system has a contact surface area of 3.9 cm 2 , and contains 0.982 mg of estradiol USP. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The estradiol transdermal system, USP comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1. a translucent polyethylene film. 2. an acrylate adhesive matrix containing estradiol USP. 3. A protective liner of silicon coated polyester film is attached to the adhesive surface and must be removed before the transdermal system can be used. Cross Section of the System: Estradiol transdermal system, USP is packaged with additional pieces of protective film above and below the system within each pouch. These are discarded at the time of use. The active component of the transdermal system is estradiol USP. The remaining components of the transdermal system (acrylic adhesive, colloidal silicon dioxide, ethyl oleate, glyceryl monolaurate, isopropyl myristate, povidone, and polyethylene backing) are pharmacologically inactive. FDA approved drug release test specifications differ from USP. Estradiol Transdermal System, 14 mcg/day Estradiol Transdermal System, 14 mcg/ day

Estradiol transdermal system, USP (twice-weekly) contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP (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 2.7, 4.05, 5.40, 8.1, or 10.8 cm 2 and contains 0.405, 0.608, 0.810, 1.215, or 1.620 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol is C 18 H 24 O 2 . The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP (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 polyethylene film (2) an adhesive formulation containing estradiol, acrylic adhesive, colloidal silicon dioxide, oleic acid, povidone, propylene glycol, and silicone adhesive and (3) a fluoropolymer coated polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. Estradiol transdermal systems, USP (twice-weekly) are packaged with additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. FDA approved drug release test specifications differ from USP. structure tds-layers