apotex corp. - Medication Listings

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- 2H -isoindol-2-yl) piperidine-2,6-dione The molecular formula for lenalidomide is C 13 H 13 N 3 O 3 , and the gram molecular weight is 259.26 g/mol. Lenalidomide is an off-white to pale-yellow powder. It is freely soluble in dimethylsulfoxide, slightly soluble in acetonitrile and methanol, very slightly soluble in ethyl acetate, and practically insoluble, or insoluble in water, absolute ethanol, hexane and isopropanol. 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 crystalline anhydrous lenalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg, 10 mg and 20 mg capsule shell contains FD&C blue #2, gelatin, iron oxide yellow, titanium dioxide and black ink. The 15 mg capsule shell contains FD&C blue #2, gelatin, titanium dioxide and black ink. The capsule imprinting black ink contains ammonium hydroxide 28%, iron oxide black, propylene glycol and shellac.

Levetiracetam extended-release tablets, USP are an antiepileptic drug available as 500 mg, 750 mg and 1,000 mg (white) extended-release tablets, USP for oral administration. The chemical name of levetiracetam, a single enantiomer, is (αS)-α-ethyl-2-oxo-1-pyrrolidineacetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam USP is a white to off-white powder. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam extended-release tablets, USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Meets USP Dissolution Test 5.

Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2 S )-2,6-Diamino­- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 17 H 33 N 3 O 7 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 freely soluble in water and practically insoluble in methylene chloride. Information for Lisdexamfetamine Dimesylate Capsules: 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: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The capsule shells contain gelatin, titanium dioxide, and one or more of the following: D&C Red #28 (70 mg), FD&C Blue #1 (40 mg, 50 mg, 60 mg and 70 mg), FD&C Red #3 (10 mg and 30 mg), FD&C Red #40 (70 mg), FD&C Yellow #6 (30 mg and 70 mg), iron oxide black (40 mg), and iron oxide yellow (20 mg and 40 mg). The imprinting ink of the 10 mg capsules contains iron oxide black, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. The imprinting ink of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze.

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Memantine hydrochloride oral solution is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients: citric acid (anhydrous), glycerin, methylparaben, peppermint oil, propylene glycol, propylparaben, purified water, sodium citrate (dihydrate) and sorbitol solution 70%. Structural Formula

Name: Midodrine hydrochloride tablets, USP Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg Inactive Ingredients: Colloidal silicone dioxide, FD&C Blue #1 (10 mg tablet), FD&C Yellow #6 (5 mg tablet), magnesium stearate, microcrystalline cellulose, starch Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-((beta)-hydroxy-2,5-dimethoxyphenethyl) acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural Formula: Molecular Formula: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: Odorless, white, crystalline powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200°C to 203°C

Mirtazapine tablets contain mirtazapine. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2­-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the empirical formula of C 17 H 19 N 3 . Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture: Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine. Each tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. In addition, mirtazapine tablets, USP 15 mg and 30 mg contains iron oxide yellow and mirtazapine tablets, USP 30 mg contains iron oxide red.

Modafinil, USP is a wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35. The chemical structure is: Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose. Modafinil Tablets meet USP Dissolution Test 3.

Mometasone furoate, the active component of mometasone furoate nasal spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione17-(2 furoate), and the following chemical structure: Mometasone furoate is a white to off-white powder, with an molecular formula of C 27 H 30 Cl 2 O 6 , and a molecular weight of 521.43. It is practically insoluble in water, slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone, chloroform, and methylene chloride; and freely soluble in tetrahydrofuran, acetone and dichloromethane. Its partition coefficient between octanol and water is greater than 5,000. Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of 0.05% w/w mometasone furoate in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, and sodium citrate. The pH is between 4.3 and 4.9. structure

Moxifloxacin ophthalmic solution, USP 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinoline carboxylic acid, monohydrochloride monohydrate. Moxifloxacin hydrochloride monohydrate is a light yellow or yellow powder or crystals. Each mL of moxifloxacin ophthalmic solution, USP contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, sodium hydroxide and water for injection. May also contain hydrochloric acid and/or additional sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg. chemical

Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as ( E )-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its molecular formula is C 17 H 19 O 6 Na. The molecular weight is 342.32 g/mol and the structural formula is Mycophenolic acid, as the sodium salt, is a white to off-white powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, hypromellose, methylcellulose, polyethylene glycol, sodium lauryl sulfate and stearic acid. The enteric coating of the tablet consists of ferric oxide red (360 mg), ferric oxide yellow, indigotine al lake (180 mg), methacrylic acid and ethyl acrylate copolymer dispersion, talc, titanium dioxide, and triethyl citrate. mycophenolic-structure

Nilotinib capsules contain nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to off-white powder with the molecular formula and weight, respectively, of C 28 H 22 F 3 N 7 O•HCl • H 2 O and 584 g/mole (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mole respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK a 1 was determined to be 2.1; pK a 2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below: Nilotinib capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 165 mg, and 221 mg nilotinib hydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer. The capsule shells contain gelatin, iron oxide red (50 mg and 150 mg), iron oxide yellow and titanium dioxide. The capsules are imprinted with edible black ink or maroon ink. The black ink is comprised of ammonium hydroxide, iron oxide black, propylene glycol and shellac. The maroon ink is comprised of ammonia solution, D&C Red #7 calcium lake, FD&C Blue #2 aluminum lake, FD&C Red # 40 aluminum lake, propylene glycol and shellac. chemical structure of nilotinib

NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35. The chemical structure is: Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. structural formula

Ofloxacin ophthalmic solution, USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido[1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. Contains: Active: Ofloxacin 0.3% (3 mg/mL) Preservative: Benzalkonium chloride 0.005%; Inactives: Hydrochloric acid, sodium chloride and water for injection. Sodium hydroxide may be added to adjust the pH. Ofloxacin ophthalmic solution, USP 0.3% is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. ofloxacin-01

Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxy-quinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido[1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. The empirical formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.38. The structural formula is: Ofloxacin Otic Solution contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), hydrochloric acid, sodium chloride, and water for injection. Additional hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.5 ± 0.5).

Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.43. The chemical structure is: Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths).

Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ][1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.43 g/mol. The chemical structure is: Olanzapine is a yellow powder. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, mannitol, microcrystalline cellulose and sucralose. Meets USP Disintegration Test 2 structure

Uses Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

Uses Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Olopatadine Hydrochloride Nasal Spray, 665 micrograms (mcg) is a metered-spray for nasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Spray, is a white to off-white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e] oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C 21 H 23 NO 3 • HCl with the following chemical structure: Olopatadine Hydrochloride Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous spray with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous spray containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths ( 3 )] . Olopatadine Hydrochloride Nasal Spray also contains anhydrous dibasic sodium phosphate, benzalkonium chloride (0.01%), edetate disodium dihydrate, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. Olopatadine-HCl

The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT 3 receptor type. Its chemical name is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9 g/mol. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9.0 mg of sodium chloride, USP; 0.5 mg of citric acid monohydrate, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.0. ondansetron hydrochloride chemical structure

Oxaliplatin is a platinum-based drug with the molecular formula C 8 H 14 N 2 O 4 Pt and the chemical name of cis -[(1 R , 2 R )-1, 2-cyclohexanediamine- N , N' ] [oxalato (2-)- O , O' ] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin Injection USP, for intravenous use is supplied in vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient. structure

Oxaliplatin is a platinum-based drug with the molecular formula C 8 H 14 N 2 O 4 Pt and the chemical name of cis -[(1 R , 2 R )-1, 2-cyclohexanediamine- N , N' ] [oxalato (2-)- O , O' ] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin Injection USP, for intravenous use is supplied in vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient. structure

Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo- 5H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C 15 H 12 N 2 O 2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).

Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S) -2-[( S )-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H- benz[ de ]isoquinoline hydrochloride. The empirical formula is C 19 H 24 N 2 O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula: Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5. Structural formula for Palonosetron hydrochloride

Palonosetron Hydrochloride Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S) -2-[( S )-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H- benz[ de ]isoquinoline hydrochloride. The empirical formula is C 19 H 24 N 2 O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula: Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5. Structural formula for Palonosetron hydrochloride

Paroxetine tablets, USP contains paroxetine hydrochloride USP, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C 19 H 20 FNO 3 ·HCl. The molecular weight is 365.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 116°C to 120°C and a solubility of 5.4 mg/mL in water. Each film-coated tablet, for oral administration, contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg; 20 mg; 30 mg; 40 mg. Inactive ingredients consist of anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide. Paroxetine tablets comply with USP Related Impurities Test 1.

Paroxetine HCL CR USP, contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 ·HCl·1/2H 2 O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off‑white powder, having a melting point range of 120°C to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine HCL CR tablets, USP are intended for oral administration. Each extended‑release tablet contains 12.5 mg, 25 mg, or 37.5 mg paroxetine equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of glyceryl behenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycols, polysorbate 80, polyvinylpyrrolidone, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate and the following colorants: D&C Red No. 30 aluminum lake (25 mg), D&C Yellow No. 10 aluminum lake (12.5 mg), FD&C Blue No. 2 aluminum lake (37.5 mg), FD&C Yellow No. 6 aluminum lake (12.5 mg), red ferric oxide (25 mg) and Yellow ferric oxide (12.5 mg and 37.5 mg).

PAXIL CR, contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 ·HCl·1/2H 2 O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off‑white powder, having a melting point range of 120° C to 138°C and a solubility of 5.4 mg/mL in water. PAXIL CR tablets are intended for oral administration. Each extended‑release tablet contains 12.5 mg, 25 mg, or 37.5 mg paroxetine equivalent to 14.25 mg, 28.51 mg, or 42.76 mg of paroxetine hydrochloride, respectively. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. Inactive ingredients consist of glyceryl behenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycols, polysorbate 80, polyvinylpyrrolidone, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate and the following colorants: D&C Red No. 30 aluminum lake (25 mg), D&C Yellow No. 10 aluminum lake (12.5 mg), FD&C Blue No. 2 aluminum lake (37.5 mg), FD&C Yellow No. 6 aluminum lake (12.5 mg), red ferric oxide (25 mg) and Yellow ferric oxide (12.5 mg and 37.5 mg).

Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-Dimethyl-2 H -indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S·HCl and a molecular weight of 473.98 g/mol. Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble in aqueous solutions, being practically insoluble above pH 4. Pazopanib tablets are for oral use. Each 200-mg tablet of pazopanib tablets 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: Gray film-coat: hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide black, polyethylene glycol 8000, and titanium dioxide.

Pemetrexed for Injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium 2.5 hydrate has the chemical name L-Glutamic acid, N-[4-[2-(2-Amino-4,7-Dihydro-4-oxo-1H- pyrrolo[2,3-d]Pyrimidin-5-yl)Ethyl] Benzoyl]-L-Glutamic acid disodium 2.5 hydrate. It is a white to off-white crystalline powder with a molecular formula of C 20 H 19 N 5 Na 2 O 6 .2.5H 2 O and a molecular weight of 516.45 g/mol. The structural formula is as follows: Pemetrexed for Injection, USP is supplied as a sterile lyophilized powder for intravenous infusion available in single-dose vials. The product is a white to either light yellow or green-yellow lyophilized powder or cake. Each 750 mg vial of pemetrexed for injection, USP contains pemetrexed disodium equivalent to 750 mg pemetrexed and 750 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.

Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 3,7-Dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione that, unlike theophylline, is a hemorrheologic agent, i.e., an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The molecular formula is C 13 H 18 N 4 O 3 and its molecular weight is 278.31. The chemical structure is: USP Dissolution Test 9

Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S ,5 R ,6 R )-6-[( R )-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23 H 26 N 5 NaO 7 S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S, 3 S, 5 R )-3-methyl-7-oxo-3-(1 H -1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: Piperacillin and tazobactam for injection contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Each piperacillin and tazobactam for injection, USP 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 g of tazobactam sufficient for delivery of multiple doses. Chemical Structure Chemical Structure

Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S ,5 R ,6 R )-6-[( R )-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2- phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C 23 H 26 N 5 NaO 7 S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S, 3 S, 5 R )-3-methyl-7-oxo-3-(1 H -1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Chemical Structure Chemical Structure

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.22 g/mol. Pirfenidone 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)-pyridinone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in methanol, ethyl alcohol, acetone and chloroform. Sparingly soluble in 1 N hydrochloric acid, water and 0.1 N sodium hydroxide. The melting point is approximately 106°C to 112°C. Pirfenidone tablets, USP contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, ferric ferrous oxide (801 mg only), ferric oxide red (801 mg only), ferric oxide yellow (267 mg only), hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide.

Potassium chloride, USP is a colorless, elongated, prismatic, or cubical crystals, or white, granular powder. It is soluble in water and slightly soluble in alcohol. Chemically, potassium chloride is K-Cl with a molecular mass of 74.55 g/mol. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Natural orange flavor includes fruit extract and natural flavor.

Prasugrel tablet USP contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Prasugrel tablet is formulated as the hydrochloride salt, a racemate, which is chemically designated as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride. Prasugrel hydrochloride USP has the empirical formula C 20 H 20 FNO 3 S•HCl representing a molecular weight of 409.90. The chemical structure of prasugrel hydrochloride is: Prasugrel hydrochloride, USP is a white to practically white solid. It is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Prasugrel tablet USP is available for oral administration as 5 mg or 10 mg round, biconvex, film-coated, non-scored tablets, debossed on each side. Each yellow 5 mg tablet is manufactured with 5.49 mg prasugrel hydrochloride, USP, equivalent to 5 mg prasugrel and each beige 10 mg tablet with 10.98 mg prasugrel hydrochloride, USP, equivalent to 10 mg of prasugrel. Other ingredients include mannitol, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, stearic acid, and glyceryl behenate. The color coatings contain lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow, and iron oxide red (only in Prasugrel 10 mg tablets). Image

Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula: Pravastatin sodium 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. 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 for oral use contains 10 mg, 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide. pravastatin-structure

PROVIGIL (modafinil) is a wakefulness‑promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2‑[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15 H 15 NO 2 S and the molecular weight is 273.35. The chemical structure is: Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Chemical_image.jpg

Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-Amino-5-chloro- N -[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide monobutanedioate. The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96. The structural formula is: Prucalopride succinate is a white to an off-white powder. It is soluble in dimethylsulfoxide, water, N,N -dimethylformamide, N,N -dimethylacetamide and sparingly soluble in methanol. It is freely soluble in acidic aqueous media. However, the solubility decreases with increasing pH. It is freely soluble in water (16% w/v) but less soluble in basic solution. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, titanium dioxide, and triethyl citrate. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, titanium dioxide, and triethyl citrate.

Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [ see Clinical Pharmacology ( 12.1 ) ]. Regadenoson is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1 H -pyrazol-1-yl]. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 and its molecular weight is 390.35 g/mol. Regadenoson is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains 0.08 mg regadenoson on an anhydrous basis, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7. Structure

Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [ see Clinical Pharmacology ( 12.1 ) ]. Regadenoson is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1 H -pyrazol-1-yl]. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 and its molecular weight is 390.35 g/mol. Regadenoson is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains 0.08 mg regadenoson on an anhydrous basis, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7. Structure

Risedronate sodium tablets, USP are pyridinyl bisphosphonates that inhibit osteoclast-mediated bone resorption and modulate bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C 7 H 10 NO 7 P 2 Na •2.5 H 2 O. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium hemi-pentahydrate is the following: Molecular Weight: Anhydrous: 305.10 Hemi-pentahydrate: 350.13 Risedronate sodium, USP is a white powder. It is soluble in water and essentially insoluble in common organic solvents. Inactive Ingredients All dose strengths contain: anhydrous lactose, crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, silicon dioxide, and titanium dioxide. Dose strength-specific ingredients include: 35 mg—ferric oxide red, ferric oxide yellow; 75 mg—ferric oxide red; 150 mg -FD&C blue #2, sodium phosphate monobasic monohydrate, sodium phosphate dibasic.

Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban film coated tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.88. The structural formula is: Rivaroxaban, USP is a pure ( S )-enantiomer. It is non-hygroscopic, white to off-white powder. Rivaroxaban, USP is slightly soluble in acetone and polyethylene glycol 400, and practically insoluble in water. Each film-coated tablet contains 2.5 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and poloxamer. Additionally, the film-coating mixture contains ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. FDA approved dissolution test method and specifications differ from USP.

Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l- deprenyl. The chemical name is: (R)-(-)- N ,α-Dimethyl- N-2 -propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The molecular formula is C 13 H 17 N . HCI and the structural formula is as follows: Each capsule, for oral administration contains 5 mg of selegiline hydrochloride. In addition, each capsule contains the following inactive ingredients: Anhydrous Lactose NF, Citric Acid Anhydrous USP, Microcrystalline Cellulose NF PH102, Stearic Acid NF and Talc USP. The capsule shell contains Gelatin NF, FD & C Blue #1 and Titanium Dioxide. The capsule logo ink Black SW-9008/SW-9009 contains the following inactive ingredients: Ammonium Hydroxide; Black Iron Oxide, Bacteria Controlled EEC No. 172; n-Butyl NF; Ethyl Alcohol, Anhydrous, 200 Proof; Isopropyl Alcohol USP; Potassium Hydroxide NF; Propylene Glycol USP; Purified Water USP and Shellac NF.

Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)- N ,2-dimethyl- N -2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The molecular formula is C 13 H 17 •HCl. The structural formula is as follows: Each tablet, for oral administration, contains 5 mg selegiline hydrochloride. Inactive ingredients are citric acid, anhydrous lactose, magnesium stearate, and microcrystalline cellulose.

Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (2S, 10R, 11R, 14S, 16S, 18E, 20E, 22E, 23S, 25R, 27R, 28R, 30E, 31R, 34S)- 2, 3, 4, 5, 10, 11, 12, 13, 14, 15, 16, 23, 24, 25, 27, 28-hexadecahydro-10, 28-dihydroxy-34-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]- 16, 27-dimethoxy-11, 17, 23, 25, 29,31-hexamethyl-10,14-epoxy-34H-pyrido[2,1-c][1,4]-oxaazacyclohentriacontine-1, 8, 9, 26,32 (6H, 31H, 33H)-pentone. Its molecular formula is C 51 H 79 NO 13 and its molecular weight is 914.17 g/mol. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in ether, chloroform, acetone, methanol, dimethylformamide, isopropanol and ethyl acetate. Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in sirolimus oral solution are Phosal 50 PG ® (ascorbyl palmitate, ethanol, lysophosphatidylcholine, phosphatidylcholine, propylene glycol, sunflower mono- diglycerides, and water) and polysorbate 80. Sirolimus oral solution contains 1.5% to 2.5% ethanol. Chemical Structure

Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white or light yellow powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: lactose monohydrate, corn starch, hypromellose 2910, magnesium stearate, talc, polyethylene glycol and titanium dioxide with iron oxide yellow (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet). structure of Solifenacin succinate

Sotalol hydrochloride/Sotalol hydrochloride AF tablets, USP contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta­-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride tablets, USP are supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride AF is supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8 g/mol. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l- N -[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12 H 20 N 2 O 3 S∙HCl and is represented by the following structural formula: Each Sotalol Hydrochloride tablet, USP/Sotalol Hydrochloride AF tablets, USP for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. In addition, each tablet also contains the following inactive ingredients: magnesium stearate and microcrystalline cellulose.

Tasimelteon is a melatonin receptor agonist, chemically designated as (1 R-trans )- N -[[2-(2,3-Dihydrobenzofuran-4-yl)cycloprop-1-yl]methyl]propanamide, containing two chiral centers. The molecular formula is C 15 H 19 NO 2 , and the molecular weight is 245.32 g/mol. The structural formula is: Tasimelteon is a white to off-white powder. It is very slightly soluble in cyclohexane, slightly soluble in water and freely soluble or very soluble in methanol, 95% ethanol, acetonitrile, isopropanol, propylene glycol and ethyl acetate. Tasimelteon capsules are intended for oral administration. Each capsule contains 20 mg of tasimelteon and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Each hard gelatin capsule consists of FD&C Blue #1, FD&C Red #3, and FD&C Yellow #6, gelatin and titanium dioxide. The imprinting ink consists of povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.