teva pharmaceuticals, inc. - Medication Listings

Levothyroxine sodium tablets, USP are L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has a molecular formula of C 15 H 10 I 4 N NaO 4 • H 2 O, molecular weight of 798.86 (anhydrous), and structural formula as shown: Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and purified water. Each tablet strength meets USP Dissolution Test 2. Table 9 provides a listing of the color additives by tablet strength: Table 9. Levothyroxine Sodium Tablets, USP Color Additives Strength (mcg) Color additive(s) 25 FD&C Yellow No. 6 Aluminum Lake* 50 None 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 88 FD&C Blue No. 2 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake* 100 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake* 112 Carmine 125 FD&C Yellow No. 6 Aluminum Lake*, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 FD&C Blue No. 2 Aluminum Lake, Carmine 200 FD&C Red No. 40 Aluminum Lake 300 FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum Lake * Note – FD&C Yellow No. 6 is orange in color. 1

Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its structural formula is: C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S M.W. 567.1 Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. chemical structure

The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is: Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: ammonium hydroxide, black iron oxide, corn starch, gelatin, mannitol, propylene glycol, red iron oxide, shellac, talc, titanium dioxide, yellow iron oxide and may contain potassium hydroxide and sodium lauryl sulfate. In addition, the 100 mg strength contains simethicone. 1

Amphetamine extended-release orally disintegrating tablets contain a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in amphetamine extended-release orally disintegrating tablets whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula: Amphetamine extended-release orally disintegrating tablets is an extended-release orally disintegrating tablet containing 45% immediate-release and 55% delayed-release amphetamine for once daily dosing. Amphetamine extended-release orally disintegrating tablets also contain the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, fructose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, pineapple flavor, sodium polystyrene sulfonate, sucralose, povidone K-30, talc, triethyl citrate and yellow iron oxide. 1

Adapalene and benzoyl peroxide topical gel, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene USP, 0.3% and benzoyl peroxide USP, 2.5%. Adapalene USP, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene, USP is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula: Adapalene, USP: Molecular formula: C 28 H 28 O 3 Molecular weight: 412.5 Benzoyl peroxide, USP is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide, USP is dibenzoyl peroxide. It has the following structural formula: Benzoyl Peroxide, USP: Molecular formula: C 14 H 10 O 4 Molecular weight: 242.23 Adapalene and benzoyl peroxide topical gel 0.3%/2.5% contains the following inactive ingredients: carbomer 980, docusate sodium, edetate disodium, glycerin, poloxamer 124, propylene glycol, purified water, sodium hydroxide, and sorbitan monooleate. 1 1

ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C 30 H 35 N 5 O 5 . The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula: Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8. ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are: Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating: Strength 9 mg: FD&C Blue No. 1 aluminum lake, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. 18 mg: Hypromellose 2910, polyethylene glycol 4000, talc, and titanium dioxide. 36 mg: Iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. 54 mg: FD&C Red #40 aluminum lake, hypromellose 2910, iron oxide yellow, polyethylene glycol 400, and titanium dioxide. structure

ALYQ ® (tadalafil, USP), an oral treatment for pulmonary arterial hypertension, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil, USP has the molecular formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.40. The structural formula is: The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a white or almost white powder that is practically insoluble in water, slightly soluble in methylene chloride, and freely soluble in dimethylsulfoxide. ALYQ ® (tadalafil tablets, USP) is available as white to off-white, oval shaped, film-coated tablets for oral administration. Each tablet contains 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, pregelatinized (corn) starch, sodium lauryl sulfate, titanium dioxide, and triacetin. structural formula

Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel, USP (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, USP (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Levonorgestrel, USP C 21 H 28 O 2 M.W. 312.45 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Levonorgestrel Ethinyl Estradiol

Azelastine hydrochloride and fluticasone propionate nasal spray is formulated as a white, uniform metered-spray suspension for nasal administration. It is a fixed dose combination product containing an antihistamine (H 1 receptor antagonist) and a corticosteroid as active ingredients. Azelastine hydrochloride, USP active ingredient occurs as a white or almost white, odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.36. It is sparingly soluble in water, and is soluble in ethanol and in dichloromethane. It has a melting point of 225°C and the pH of 5.2. Its chemical name is 1-(2 H )-phthalazinone, 4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1 H -azepin-4-yl), monohydrochloride. Its molecular formula is C 22 H 24 ClN 3 O•HCl with the following chemical structure: Fluticasone propionate, USP active ingredient is a white or almost white powder with a melting point of 273°C, a molecular weight of 500.57, and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, sparingly soluble in methylene chloride, and slightly soluble in alcohol. Fluticasone propionate, USP is a synthetic corticosteroid having the chemical name Androsta-1,4-diene-17-carbothioic acid,6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-,(6α, 11β, 16α, 17α)- S -(fluoromethyl) ester, and the following chemical structure: Azelastine hydrochloride and fluticasone propionate nasal spray, 137 mcg/50 mcg contains 0.1% solution of azelastine hydrochloride and 0.037% suspension of micronized fluticasone propionate in an isotonic aqueous suspension containing benzalkonium chloride (0.1 mg/g), edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol (2.5 mg/g), polysorbate 80, and Water for Injection, USP q.s. It has a pH of approximately 6.0. After priming [see Dosage and Administration (2.2)] , each metered spray delivers a 0.137 mL mean volume of suspension containing 137 mcg of azelastine hydrochloride (equivalent to 125 mcg of azelastine base) and 50 mcg of fluticasone propionate. The 23 g bottle provides 120 metered sprays, after priming. 1 1

Cetrorelix acetate for injection is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10. The molecular formula is Acetyl-D-3-(2′-naphtyl)-alanine-D-4-chlorophenylalanine-D-3-(3′-pyridyl)-alanine-L-serine-L-tyrosine-D-citruline-L-leucine-L-arginine-L-proline-D-alanine-amide, and the molecular weight is 1431.06, calculated as the anhydrous free base. The structural formula is as follows: Cetrorelix acetate (Ac-D-Nal 1 - D -Cpa 2 - D -Pal 3 -Ser 4 -Tyr 5 - D -Cit 6 -Leu 7 -Arg 8 -Pro 9 - D -Ala 10 -NH 2 ) Cetrorelix acetate for injection 0.25 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, that comes supplied in a 1.0 mL pre-filled syringe. Each vial of cetrorelix acetate for injection 0.25 mg contains 0.26-0.27 mg cetrorelix acetate, equivalent to 0.25 mg cetrorelix, and 54.80 mg mannitol. Structural Formula

Cryselle ® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. The light green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP C 21 H 28 O 2 MW: 312.45 Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.40 1 2

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: C 62 H 111 N 11 O 12 M.W. 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: carbomer copolymer type A, castor oil, glycerin, polysorbate 80, water for injection and sodium hydroxide to adjust pH. 1

Dalbavancin for injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A 0 , A 1 , B 0 , B 1 , and B 2 ); the component B 0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R 1 ) structure and/or the presence of an additional methyl group (R 2 ) on the terminal amino group (shown in the Figure 1 and Table 3 below). Figure 1. Dalbavancin Structural Formula Table 3. Substitution Patterns for Dalbavancin API Homologs Dalbavancin R 1 R 2 Molecular Formula Molecular Weight * A 0 CH(CH 3 ) 2 H C 87 H 98 N 10 O 28 Cl 2 · 1.6 HCl 1,802.7 A 1 CH 2 CH 2 CH 3 H C 87 H 98 N 10 O 28 Cl 2 · 1.6 HCl 1,802.7 B 0 CH 2 CH(CH 3 ) 2 H C 88 H 100 N 10 O 28 Cl 2 · 1.6 HCl 1,816.7 B 1 CH 2 CH 2 CH 2 CH 3 H C 88 H 100 N 10 O 28 Cl 2 · 1.6 HCl 1,816.7 B 2 CH 2 CH(CH 3 ) 2 CH 3 C 89 H 102 N 10 O 28 Cl 2 · 1.6 HCl 1,830.7 *Anhydrous free base The B 0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O-[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients. Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for intravenous infusion [ see Dosage and Administration ( 2.4 ) , How Supplied/Storage and Handling ( 16 ) ] . Figure 1. Dalbavancin Structural Formula

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 formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure: Dasatinib is a white to off-white fine crystalline powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, beveled edge, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets contain a coating that consists of hypromellose 2910, titanium dioxide, and triacetin. 1

Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is: C 21 H 15 N 3 O 4 M.W. 373.36 Deferasirox is a white to almost white powder. Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate. Chemical structure

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate and amphetamine sulfate, dextroamphetamine saccharate and amphetamine aspartate monohydrate. This results in a 3:1 mixture of dextro- to levo- amphetamine base equivalent. The 12.5 mg, 25 mg, 37.5 mg and 50 mg strength capsules are for oral administration. They are designed to contain two types of drug extended release pellets. One type of extended release pellets contains an outer coating of drug to immediately release drug upon administration. CAPSULE STRENGTHS EACH CAPSULE CONTAINS: 12.5 mg 25 mg 37.5 mg 50 mg Dextroamphetamine Saccharate 3.125 mg 6.250 mg 9.375 mg 12.500 mg Amphetamine Aspartate Monohydrate 3.125 mg 6.250 mg 9.375 mg 12.500 mg Dextroamphetamine Sulfate 3.125 mg 6.250 mg 9.375 mg 12.500 mg Amphetamine Sulfate 3.125 mg 6.250 mg 9.375 mg 12.500 mg Total mixed amphetamine salts 12.500 mg 25 mg 37.5 mg 50 mg Total amphetamine base equivalence 7.8 mg 15.6 mg 23.5 mg 31.3 mg Inactive Ingredients : ethylcellulose, hypromellose 2910, iron oxide red, iron oxide yellow, methacrylic acid copolymer dispersion; methyl acrylate, methyl methacrylate, and methacrylic acid copolymer; polyethylene glycol 400, polysorbate 80, sugar spheres (which contains corn starch and sucrose), talc, titanium dioxide, and triethyl citrate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide. In addition, the 12.5 mg capsule shell contains carboxymethylcellulose, iron oxide red, and iron oxide yellow; the 25 mg capsule shell contains carboxymethylcellulose, FD&C Blue #1, iron oxide red, and iron oxide yellow; the 37.5 mg capsule shell contains carboxymethylcellulose, FD&C Blue #1 and FD&C Red #40, and iron oxide red; 50 mg capsule shell contains FD&C Blue #1 and FD&C Red #40. The printing ink for 12.5 mg, 25 mg, and 37.5 mg capsule contains ammonium hydroxide, iron oxide black, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. The printing ink for the 50 mg capsule contains ammonium hydroxide, povidone, propylene glycol, simethicone (which contains dimethicone and silicon dioxide), shellac, sodium hydroxide, and titanium dioxide.

Diclofenac potassium capsules are a nonsteroidal anti-inflammatory drug, available as liquid-filled capsules of 25 mg for oral administration. Diclofenac potassium, USP is a white to slightly yellowish crystalline powder. It is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.24. Its molecular formula is C 14 H 10 Cl 2 NKO 2 , and it has the following chemical structure. The inactive ingredients in diclofenac potassium capsules include: lactic acid, polyethylene glycol, polysorbate 80, povidone, and water. The capsule shells contain bovine hydrolyzed collagen, gelatin, lecithin, medium chain triglycerides, sorbitans, sorbitol, and water. The capsules are printed with black ink composed of black iron oxide, polyvinyl acetate phthalate, polyethylene glycol and propylene glycol. Structure

Fidaxomicin is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4- O -(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)- 2- O -methyl-β-D-mannopyranosyl]oxy]methyl]-12-[[6-deoxy-5- C -methyl-4- O -(2-methyl-1-oxopropyl)-β-D- lyxo -hexopyranosyl]oxy]-11-ethyl-8-hydroxy-18-[(1 R )-1-hydroxyethyl]-9,13,15-trimethyl-, (3 E ,5 E ,8 S ,9 E ,11 S ,12 R ,13 E ,15 E ,18 S )-. The molecular formula is C 52 H 74 Cl 2 O 18 and the molecular weight is 1058.04 g/mol. The structural formula of fidaxomicin is shown in Figure 1. Figure 1: Structural Formula of Fidaxomicin Fidaxomicin tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, pregelatinized corn starch, sodium starch glycolate Type A, talc, and titanium dioxide. 1

Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride, USP is a white to off-white solid that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each capsule contains the following inactive ingredients: pregelatinized starch (corn) and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, and titanium dioxide. In addition, the imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. structure

Gefitinib is a kinase inhibitor. The chemical name of gefitinib is 4-Quinazolinamine N -(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl) propoxy] and the following structural formula: Gefitinib has the molecular formula C 22 H 24 ClFN 4 O 3 , a relative molecular mass of 446.9 daltons and is a white-colored powder. Gefitinib is a free base. The molecule has pK a s of 5.4 and 7.2. Gefitinib can be defined as sparingly soluble at pH 1, but is practically insoluble above pH 7, with the solubility decreasing sharply between pH 4 and pH 6. In non-aqueous solvents, gefitinib is freely soluble in glacial acetic acid and dimethyl sulfoxide, soluble in pyridine, sparingly soluble in tetrahydrofuran, and slightly soluble in methanol, ethanol (99.5%), ethyl acetate, propan-2-ol and acetonitrile. Gefitinib tablets are available as light brown to brown film-coated tablets, containing 250 mg of gefitinib, for oral administration. The inactive ingredients of the tablet core of gefitinib tablets are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate. The tablet coating is composed of polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide. 1

Icosapent ethyl, a lipid-regulating agent, is supplied as either a 500 milligram or a 1 gram, transparent, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains either 500 milligrams of icosapent ethyl (in a 500 milligram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.5. The chemical name for icosapent ethyl is all-cis-5,8,11,14,17-eicosapentaenoic acid ethyl ester with the following chemical structure: Icosapent ethyl capsules also contain the following inactive ingredients: dl-alpha-tocopherol, ethyl acetate, gelatin, glycerin anhydrous, iron oxide black, polyethylene glycol 400, polyvinyl acetate phthalate, propylene glycol, and purified water. formula

Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name N -(3-chloro-4-{[(3- fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4- quinazolinamine bis(4-methylbenzenesulfonate) monohydrate. It has the molecular formula C 29 H 26 ClFN 4 O 4 S (C 7 H 8 O 3 S) 2 H 2 O and a molecular weight of 943.5 g/mol. Lapatinib ditosylate monohydrate has the following chemical structure: Lapatinib is a yellow solid, and its solubility in water is 0.007 mg/mL and in 0.1N HCl is 0.001 mg/mL at 25°C. Each 250 mg tablet of lapatinib contains 405 mg of lapatinib ditosylate monohydrate, equivalent to 398 mg of lapatinib ditosylate or 250 mg lapatinib free base. The inactive ingredients of lapatinib tablets are as follows: iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol (part hydrolyzed), povidone, sodium starch glycolate Type A, talc, and titanium dioxide. chemical structure

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3 , and the gram molecular weight is 259.3. Lenalidomide is a cream to light yellow color powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose. The capsule shell ingredients common to all strengths are gelatin and titanium dioxide. Additionally, the 20 mg capsule contains FD&C Blue #1, FD&C Yellow #6, and iron oxide yellow. Each capsule is printed with black ink, which includes black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. 1

Liraglutide injection contains liraglutide, an analog of the fragment 7-37 of the naturally occurring human glucagon-like peptide 1 (GLP-1[7 - 37]), containing one amino acid substitution (Arg for Lys at position 34 of the GLP-1 sequence) and an additional fatty acid chain. Liraglutide is a linear peptide with 31 amino acids and a γ-glutamyl-palmitoyl residue linked to the ɛ-amino group of Lys 20 . All amino acid residues with exception of the archiral glycines are in the L-configuration. The structural formula (Figure 1) is: C 172 H 265 N 43 O 51 M.W. 3751.26 Daltons Figure 1. Structural Formula of liraglutide Liraglutide is manufactured by chemical synthesis. Liraglutide injection is a sterile, aqueous, clear, colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: phenol, 5.5 mg; propylene glycol, 14 mg; sodium phosphate dibasic dihydrate, 1.42 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each pre-filled pen contains a 3 mL solution of liraglutide injection equivalent to 18 mg liraglutide (free-base, anhydrous). structural formula

Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O•(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.60. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The capsule shells contain gelatin and titanium dioxide. The 10 mg capsule shells also contain D&C Red #28, FD&C Blue #1, and FD&C Red #40. The 20 mg capsule shells also contain yellow iron oxide. The 30 mg capsule shells also contain D&C Red #28, FD&C Blue #1, FD&C Red #40 and yellow iron oxide. The 40 mg capsule shells also contain D&C Yellow #10, FD&C Green #3, and yellow iron oxide. The 50 mg capsule shells also contain FD&C Blue #1 and yellow iron oxide. The 60 mg capsule shells also contain D&C Yellow #10 and FD&C Green #3. The 70 mg capsule shells also contain FD&C Red #40 and yellow iron oxide. The capsules are printed with black ink which contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. 1

Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O•(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.59. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, and artificial strawberry flavor (which contains artificial flavors, corn syrup, medium-chain triglycerides, and modified corn starch). 1

Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (–)-7-[(2 R ,4a R ,5 R ,7a R )-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[ b ]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C 20 H 32 F 2 O 5 with a molecular weight of 390.47 and a chemical structure as follows: Lubiprostone drug substance occurs as off-white to white crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water. Lubiprostone capsules are available as imprinted, oval, soft gelatin capsules in two strengths. Pink capsules contain 8 mcg of lubiprostone and the following inactive ingredients: black iron oxide, ferric oxide red, gelatin, hypromellose, lecithin, medium-chain triglycerides, propylene glycol, purified water, sorbitol sorbitan solution, and titanium dioxide. Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients: black iron oxide, D&C Yellow No. 10, FD&C Red No. 40, gelatin, hypromellose, lecithin, medium-chain triglycerides, propylene glycol, purified water, and sorbitol sorbitan solution. 1

Each mesalamine delayed-release tablet, USP for oral administration contains 800 mg of mesalamine, USP, an aminosalicylate. Mesalamine delayed-release tablets, USP have an outer protective coat consisting of a combination of acrylic based resins, methacrylic acid and methyl methacrylate copolymer (1:2) and methacrylic acid and methyl methacrylate copolymer (1:1). The inner coat consists of an acrylic based resin, methacrylic acid and methyl methacrylate copolymer (1:2), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is: Molecular Weight: 153.1 Molecular Formula: C 7 H 7 NO 3 Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl sebacate, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, povidone K-30, sodium starch glycolate (type A), talc, and titanium dioxide. In addition the imprinting white ink contains isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze. 1

Uses to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life

Naproxen sodium extended-release tablets are a nonsteroidal anti-inflammatory drug, available as extended-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C 14 H 13 NaO 3 , and it has the following chemical structure. Naproxen sodium, USP is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. Naproxen sodium extended-release tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, USP equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each naproxen sodium extended-release tablet also contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, ethyl acrylate/methyl methacrylate copolymer, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and propylene glycol. The tablet coating contains hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. 1

Each white Nora-BE ® tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include lactose, magnesium stearate, povidone, and starch. The chemical name for norethindrone is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows: norethindrone Therapeutic class = oral contraceptive. Norethindrone structural formula.

Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Octreotide is known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)]. The molecular weight of octreotide is 1019.3 g/mol (free peptide, C 49 H 66 N 10 O 10 S 2 ) and its amino acid sequence is: Octreotide acetate for injectable suspension is available in a single-dose vial containing the sterile drug product, which when mixed with diluent, becomes a suspension that is given as a monthly intragluteal injection. The octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol is added to the microspheres to improve suspendability. Octreotide acetate for injectable suspension is available as: sterile 8-mL single-dose vials in 3 strengths delivering 10 mg, 20 mg, or 30 mg octreotide-free peptide. Each single-dose vial of octreotide acetate for injectable suspension delivers: Name of Ingredient 10 mg 20 mg 30 mg octreotide acetate, USP 11.2 mg * 22.4 mg * 33.6 mg * D,L-lactic and glycolic acids copolymer 188.8 mg 377.6 mg 566.4 mg mannitol 41.0 mg 81.9 mg 122.9 mg *Equivalent to 10 mg, 20 mg, or 30 mg octreotide, respectively. Each prefilled syringe of diluent contains: carboxymethylcellulose sodium 14 mg mannitol 12 mg poloxamer 188 4 mg water for injection q.s. to 2 mL 1

Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is paclitaxel, formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine. The molecular formula is C 47 H 51 NO 14 and the molecular weight is 853.91. Paclitaxel has the following structural formula: Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C. Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection prior to intravenous infusion. Each single-dose vial contains 100 mg of paclitaxel, approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate), and approximately 23 mg sodium chloride. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is free of solvents. 1

Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide hydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S•HCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. Pazopanib tablets are for oral use. Each 200 mg tablet of pazopanib contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of pazopanib tablets are: Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: Grey film-coat: hypromellose 2910, iron oxide black, polyethylene glycol 400, polysorbate 80, and titanium dioxide. new

Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed diacid monohydrate, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1 H -pyrrolo[2,3- d ] pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid, monohydrate with a molecular formula of C 20 H 21 N 5 O 6 • H 2 O and a molecular weight of 445.43. It is practically insoluble in water. The structural formula is as follows: Pemetrexed Injection is supplied as a sterile solution for intravenous infusion available in single-dose vials. The product is a clear to slightly yellowish or slightly yellow-greenish solution. Each mL contains 25 mg pemetrexed, 35 mg tromethamine, 10 mg citric acid anhydrous, 0.5 mg methionine and water for injection. Tromethamine may have been added to adjust pH. 1

Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile The molecular formula is C 23 H 15 N 3 O and the molecular weight is 349.38 (for anhydrous perampanel). It is a white to yellowish solid. It is freely soluble in dichloromethane and N-methyl-2-pyrrolidone, sparingly soluble in acetone and acetonitrile, slightly soluble in ethanol, ethyl acetate, methanol, and toluene, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in n-hexane and water. The chemical structure is: Perampanel tablets are round, biconvex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, the 2 mg, 4 mg, 6 mg, and 8 mg contain iron oxide red, the 2 mg and 10 mg contain iron oxide yellow, and the 8 mg, 10 mg, and 12 mg contain FD&C Blue No. 2 (indigo carmine) Aluminum Lake. new

Phentermine and topiramate extended-release capsules are comprised of immediate-release phentermine hydrochloride (expressed as the weight of the free base) and extended-release topiramate. Phentermine and topiramate extended-release capsules contain phentermine hydrochloride USP, a sympathomimetic amine anorectic, and topiramate USP, a sulfamate-substituted monosaccharide. Phentermine Hydrochloride, USP The chemical name of phentermine hydrochloride, USP is α,α-dimethylphenethylamine hydrochloride. The molecular formula is C 10 H 15 N • HCl and its molecular weight is 185.7 (hydrochloride salt) or 149.2 (free base). Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder that is soluble in water, methanol, and ethanol. Its structural formula is: Topiramate, USP Topiramate, USP is 2,3:4,5-di-O-isopropylidene-β-D-fructopyranose sulfamate. The molecular formula is C 12 H 21 NO 8 S and its molecular weight is 339.4. Topiramate, USP is a white to off-white crystalline powder with a bitter taste. It is freely soluble in methanol and acetone, sparingly soluble in pH 9 to pH 12 aqueous solutions and slightly soluble in pH 1 to pH 8 aqueous solutions. Its structural formula is: Phentermine and topiramate extended-release capsules are for oral administration and available in four dosage strengths: 3.75 mg/23 mg (phentermine 3.75 mg and topiramate 23 mg extended-release) (equivalent to 4.67 mg of phentermine hydrochloride, USP). 7.5 mg/46 mg (phentermine 7.5 mg and topiramate 46 mg extended-release) (equivalent to 9.33 mg of phentermine hydrochloride, USP). 11.25 mg/69 mg (phentermine 11.25 mg and topiramate 69 mg extended-release) (equivalent to 14.0 mg of phentermine hydrochloride, USP). 15 mg/92 mg (phentermine 15 mg and topiramate 92 mg extended-release) (equivalent to 18.66 mg of phentermine hydrochloride, USP). Each capsule contains the following inactive ingredients: colloidal silicon dioxide, copovidone, ethylcellulose, gelatin, hypromellose, microcrystalline cellulose, polysorbate 80, povidone K-30, sugar spheres (which contain sucrose and corn starch), talc, and titanium dioxide. The 3.75 mg/23 mg strength also contains iron oxide red and iron oxide yellow. The 7.5 mg/46 mg strength also contains FD&C Blue #2 and iron oxide yellow. The 11.25 mg/69 mg strength also contains iron oxide yellow. The 15 mg/92 mg strength also contains iron oxide red. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze. 1 1

Pirfenidone, USP belongs to the chemical class of pyridone. Pirfenidone tablets, USP are available for oral administration as film-coated tablets containing 267 mg (yellow) and 801 mg (purple) pirfenidone, USP. Pirfenidone, USP has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone, USP has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone, USP is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone tablets, USP contain pirfenidone, USP and the following inactive ingredients: black iron oxide, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, and titanium dioxide. In addition, the 801 mg strength contains iron oxide red. formula

Pitavastatin tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis {(3R, 5S, 6 E )-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate}. The structural formula is: The empirical formula for pitavastatin is C 50 H 46 CaF 2 N 2 O 8 and the molecular weight is 880.98. Pitavastatin is odorless and occurs as white to pale-yellow powder. It is freely soluble in pyridine, chloroform, dilute hydrochloric acid, and tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in octanol, slightly soluble in methanol, very slightly soluble in water or ethanol, and practically insoluble in acetonitrile or diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin tablets contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: crospovidone, lactose monohydrate, microcrystalline cellulose, magnesium oxide, magnesium stearate, povidone, sodium starch glycolate, and film coating containing the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. structural formula

Plerixafor Injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11-­tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C 28 H 54 N 8 . The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1. 1

Pravastatin sodium, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S- [1α(βS*, δS*),2α,6α,8β(R*),8aα]]-. Structural formula: Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP for oral use contain 80 mg pravastatin sodium USP, which is equivalent to 76.06 mg of pravastatin, respectively. Inactive ingredients include: anhydrous dibasic calcium phosphate, crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and povidone. 1

Propylthiouracil, USP is one of the thiocarbamide compounds. It is a white, powdery, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil is an antithyroid drug administered orally. The structural formula is: Molecular Weight: 170.23 C 7 H 10 N 2 OS Each tablet contains propylthiouracil, USP 50 mg and the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone, and pregelatinized corn starch. 1

INDICATIONS AND USAGE Treatment of Toxoplasmosis : Pyrimethamine tablets are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Risperidone for Extended-Release Injectable Suspension contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 2 and its molecular weight is 410.49. The structural formula is: Risperidone is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a white to off-white, sterile, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone per vial. Risperidone is microencapsulated in 75:25 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous, 1.27 mg/mL disodium hydrogen phosphate dihydrate, 1 mg/mL polysorbate 20, 22.5 mg/mL sodium carboxymethyl cellulose, 6 mg/mL sodium chloride, 0.54 mg/mL sodium hydroxide, and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for Extended-Release Injectable Suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter, and two Terumo SurGuard ® 3 Needles (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration). 1

Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate, USP has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4-methylbenzene sulfonate. The molecular formula of sorafenib tosylate, USP is C 21 H 16 ClF 3 N 4 O 3 x C 7 H 8 O 3 S and the molecular weight of sorafenib tosylate, USP is 637.03 g/mole. Its structural formula is: Sorafenib tosylate, USP is a white to yellowish or brownish solid. Sorafenib tosylate, USP is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400. Sorafenib tablets, USP for oral use is supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate, USP and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium lauryl sulfate, and titanium dioxide. 1

Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as oval-shaped film-coated tablets for oral administration. Each tablet contains 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sodium lauryl sulfate. The film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, talc, titanium dioxide, triacetin, and yellow iron oxide. new

Tasimelteon is a melatonin receptor agonist, chemically designated as (1 R , 2 R )-N-[2- (2,3-dihydrobenzofuran-4-yl)cyclopropylmethyl]propanamide, containing two chiral centers. The molecular formula is C 15 H 19 NO 2 , and the molecular weight is 245.32. The structural formula is: Tasimelteon is a white to off-white crystalline powder. It is very slightly soluble in cyclohexane, slightly soluble in water and 0.1 N hydrochloric acid, and freely soluble or very soluble in methanol, 95% ethanol, acetonitrile, isopropanol, polyethylene glycol 300, propylene glycol and ethyl acetate. Tasimelteon is available in 20 mg strength capsules for oral administration. Inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. Each capsule shell consists of FD&C Blue No. 1, FD&C Red No. 40, gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. 1

Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C 12 H 9 F 3 N 2 O 2 with the following chemical structure: Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow. 1

Theophylline, USP is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1 H -Purine -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula: C 7 H 8 N 4 O 2 M.W. 180.17. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: anhydrous lactose, hypromellose 2208, magnesium stearate and povidone. new

Ticagrelor is a cyclopentyltriazolopyrimidine inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP-receptor. Chemically it is (1 S ,2 S ,3 R ,5 S )-3-[7-{[(1 R ,2 S )-2-(3,4-difluorophenyl)cyclopropyl]amino}-5- (propylthio)-3 H -[1,2,3]-triazolo[4,5- d ]pyrimidin-3-yl]-5-(2­ hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23 H 28 F 2 N 6 O 4 S and its molecular weight is 522.57. The chemical structure of ticagrelor is: Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Each tablet for oral administration contains 60 mg or 90 mg of ticagrelor and the following inactive ingredients: dibasic calcium phosphate (anhydrous), hypromellose 2910, iron oxide red, iron oxide yellow, magnesium stearate, mannitol, polyethylene glycol 4000, povidone, sodium starch glycolate (type A), talc, and titanium dioxide. chemical structure