teva pharmaceuticals usa, inc. - Medication Listings

Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o -chlorophenyl)-1,3-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. 1

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg, and Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide, USP. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its structural formula is: C 22 H 22 ClKN 6 O M.W. 461.01 Losartan potassium, USP is a white to off-white free-flowing crystalline powder. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is: C 7 H 8 ClN 3 O 4 S 2 M.W. 297.74 Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan Potassium and Hydrochlorothiazide Tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide, USP. Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, pregelatinized corn starch, talc, and titanium dioxide. Additionally, 50 mg/12.5 mg tablets contain D&C Yellow #10 (Aluminum Lake) and FD&C Blue #1 (Aluminum Lake) and the 100 mg/25 mg tablets contain D&C Yellow #10 (Aluminum Lake). Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg contain 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg contain 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium. structure01 structure02

Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus . After oral ingestion, lovastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin, USP is [1 S -[1α( R *),3α,7β,8β(2 S *,4 S *),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. Its structural formula is: C 24 H 36 O 5 M.W. 404.55 Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets, USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake. lovastatin structural formula

Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is: C 24 H 34 O 4 M.W. 386.53 Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate. fig1

Mefloquine hydrochloride tablets, USP are an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228 mg of the free base) for oral administration. Mefloquine hydrochloride, USP is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. The structural formula is as follows: C 17 H 16 F 6 N 2 O.HCl M.W.: 414.78 The inactive ingredients are colloidal silicon dioxide, corn starch, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, poloxamer and talc. FDA approved dissolution test specifications differ from USP. 1

Megestrol acetate tablets, USP are a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17α-acetyloxy-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. The structural formula is represented as follows: C 24 H 32 O 4 M.W. 384.51 Megestrol acetate tablets, USP are supplied as tablets for oral administration containing 20 mg or 40 mg megestrol acetate. Inactive Ingredients: Anhydrous lactose, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Megestrol Acetate Structural Formula

Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine. description

Each Mesalamine delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, USP an aminosalicylate. Mesalamine delayed-release capsules contain acrylic based resin, methacrylic acid copolymer (Eudragit S), which dissolves at pH 7 or greater and releases 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: C 7 H 7 NO 3 M.W. 153.14 Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, shellac, sodium starch glycolate (potato), strong ammonia solution and talc. 1

Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N -[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C 20 H 22 N 8 O 5 and the molecular weight is 454.45 g/mol. The structural formula is: Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. Inactive Ingredients: Anhydrous lactose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, propylene glycol, sodium carbonate monohydrate, and talc. 22

Methylergonovine maleate is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine maleate is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Active Ingredient: methylergonovine maleate USP, 0.2 mg. Inactive Ingredients: acacia, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, corn starch, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro- N -[1- (hydroxymethyl)propyl]-6-methyl-, [8β( S )]-, ( Z )-2-butenedioate (1:1) (salt). Its structural formula is C 20 H 25 N 3 O 2 ·C 4 H 4 O 4 M.W. 455.50 FDA approved dissolution test specifications differ from USP. formula

Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant. Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows: M.W. 269.77 Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10. Structural Formula

Metoclopramide hydrochloride, USP, the active ingredient of metoclopramide tablets, USP is a dopamine-2 receptor antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate) is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro- N -[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows: C 14 H 22 ClN 3 O 2 •HCl•H 2 O M.W. 354.3 Metoclopramide tablets, USP are for oral administration. Metoclopramide tablets, USP are available in 5 mg and 10 mg tablets. Each metoclopramide tablet USP, 5 mg contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride, USP). Each metoclopramide tablet USP, 10 mg contains 10 mg metoclopramide (equivalent to 11.82 mg of metoclopramide hydrochloride, USP). Inactive Ingredients Corn starch, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. \\Client\X$\Products\Metoclopramide Tablets USP, 10 mg (ANDA 070184)\Submissions\2017-08-30 CBE-0 - AJK\Working\INSERT\Images\metoclopramide-sf1.jpg

Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 1 H -Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula: C 6 H 9 N 3 O 3 M.W. 171.15 Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil. structural formula

Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is: C 11 H 17 NO • HCl M.W. 215.72 Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: D&C Red #28 and FD&C Blue #1 and the 250 mg capsule also contains: D&C Yellow #10 and FD&C Blue #1. The imprinting ink contains: ammonium hydroxide, black iron oxide, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. Structural formula for mexiletine hydrochloride

Mimvey ® (estradiol and norethindrone acetate tablets, USP) 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol, USP and 0.5 mg of norethindrone acetate, USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, and titanium dioxide. Estradiol (E 2 ), an estrogen, is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate. The structural formula of E 2 is as follows: Estradiol, USP C 18 H 24 O 2 , 1 / 2 H 2 O M.W. 281.4 Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17β-acetoxy-19-nor-17α-pregn-4-en-20-yn-3-one. The structural formula of NETA is as follows: Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.5 Estradiol Structure Norethindrone Acetate Structure

Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is: C 27 H 34 N 2 O 7 •HCl M.W. 535.04 Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2 . Structural formula for moexipril hydrochloride

Mupirocin ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin. The chemical name is ( E )-(2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The chemical structure is: Figure 1. Structure of Mupirocin C 26 H 44 O 9 M.W. 500.63 Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. image01

Mycophenolate mofetil, USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil, USP (MMF) is 2-morpholinoethyl ( E )-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has the following structural formula: C 23 H 31 NO 7 M.W. 433.50 Mycophenolate mofetil, USP is a white to almost white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4), freely soluble in acetone, soluble in methanol, sparingly soluble in anhydrous ethanol, and practically insoluble in water. No polymorphic form was found. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil, USP are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil, USP is available for oral administration as capsules containing 250 mg of mycophenolate mofetil, USP. Inactive ingredients in Mycophenolate Mofetil Capsules, USP, 250 mg include: black iron oxide, croscarmellose sodium, D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, povidone, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Structural Formula

Naloxone hydrochloride nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride dihydrate is the hydrochloride salt of (5R,9R,13S,14S)-17-Allyl-3,14-dihydroxy-4,5-epoxymorphinan-6-on hydrochloride dihydrate with the following structure: C 19 H 22 NO 4 Cl•2H 2 O M.W. 399.87 Naloxone hydrochloride, USP an opioid antagonist, occurs as a white to slightly off-white powder, and is freely soluble in water, soluble in ethanol (96%) and practically insoluble in toluene. Each naloxone hydrochloride nasal spray contains a 4 mg single dose of naloxone hydrochloride, USP (equivalent to 3.6 mg of naloxone) in a 0.1 mL (100 microliter) aqueous solution. Inactive ingredients include benzalkonium chloride (preservative), edetate disodium (stabilizer), sodium chloride, sodium hydroxide/hydrochloric acid to adjust pH, and purified water. The pH range is 3.5 to 5.5. Structure

Nefazodone hydrochloride tablets, USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is: Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets, USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant. 1

Neomycin sulfate tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae . Structurally, neomycin sulfate may be represented as follows: C 23 H 46 N 6 O 13 ·2½ H 2 SO 4 MW 614.67 Chemically, it is 0 -2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→3)- 0 -β-D-ribofuranosyl-(1→5)- 0 -[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the a-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl. Each tablet contains 500 mg neomycin sulfate (equivalent to 350 mg neomycin base). Inactive ingredients: calcium stearate, povidone. chemical-structure

Norethindrone Acetate Tablets, USP (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. The structural formula is as follows: C 22 H 28 O 3 M.W. 340.46 Each Norethindrone Acetate Tablet, USP for oral administration, contains norethindrone acetate, USP 5 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, magnesium stearate, and microcrystalline cellulose. Norethindrone Acetate structural formula

INDICATIONS AND USAGE Nortrel 1/35 and Nortrel 0.5/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 1 Method (1) Typical Use 2 (2) Perfect Use 3 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4 Condom 8 Female (Reality ® ) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Norplant ® and Norplant-2 ® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Adapted from Hatcher et al., 1998 Ref. #1. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception. 10 Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998. 1. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 2. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral ® (1 dose is 2 white pills), Alesse ® (1 dose is 5 pink pills), Nordette ® or Levlen ® (1 dose is 2 light-orange pills), Lo/Ovral ® (1 dose is 4 white pills), Triphasil ® or Tri- Levlen ® (1 dose is 4 yellow pills). 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. Nortrel 0.5/35 and 1/35 have not been studied for and are not indicated for use in emergency contraception.

Nortrel ® 7/7/7 (norethindrone and ethinyl estradiol tablets USP, 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg): Each light yellow tablet contains 0.5 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP and the inactive ingredients include D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each blue tablet contains 0.75 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP and the inactive ingredients include FD&C blue no. 1 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each peach tablet contains 1 mg of norethindrone, USP and 0.035 mg of ethinyl estradiol, USP and the inactive ingredients include FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each white tablet contains only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized corn starch. The chemical name for norethindrone, USP is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, and for ethinyl estradiol, USP is 19-Nor-17α -pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulas are as follows: Norethindrone, USP C 20 H 26 O 2 M. W. 298.42 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Chem structure Norethindrone Chem Structure Ethyinyl Estradiol

Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5 H -dibenzo[ a,d ]cyclohepten-5-ylidene)- N -methyl-, hydrochloride. The structural formula is as follows: C 19 H 21 N•HCl M.W. 299.84 Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow No. 10, FD&C Blue No. 1, and FD&C Yellow No. 6. chemical structure

Nystatin, USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Its structural formula: C 47 H 75 NO 17 M.W. 926.13 Nystatin tablets, USP contain the inactive ingredients: corn starch, povidone, compressible sugar, microcrystalline cellulose, sodium starch glycolate, talc, magnesium stearate, purified water, and coloring. Structural formula for nystatin

OCELLA (drospirenone/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below: • 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE • 7 inert white tablets The inactive ingredients in the yellow tablets are lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, macrogol 6000 NF, titanium dioxide USP, talc USP, and ferric oxide pigment, yellow NF. The white inert film-coated tablets contain lactose monohydrate NF, microcrystalline cellulose NF, magnesium stearate NF, hypromellose USP, talc USP, and titanium dioxide USP. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: Structural Formulas

Olanzapine orally disintegrating tablets, USP are 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 and has the following chemical structure: C 17 H 20 N 4 S M.W. 312.44 Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Meets USP Disintegration Test 2. Structural Formula

Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa ® , and Zyprexa ® Zydis ® ) and fluoxetine hydrochloride, USP (the active ingredient in Prozac ® and Sarafem ® ). Olanzapine, USP 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. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride. The chemical structures are: C 17 H 20 N 4 S M.W. 312.44 C 17 H 18 F 3 NO•HCl M.W. 345.79 Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations: 3 mg/25 mg 6 mg/25 mg 6 mg/50 mg 12 mg/25 mg 12 mg/50 mg Olanzapine, USP 3 6 6 12 12 fluoxetine base equivalent 25 25 50 25 50 Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. olanzapine structure Fluoxetine Structure

Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets for oral administration are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[2'-(1 H -tetrazole-5-yl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. The amlodipine besylate, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 2-[(2-Amino-ethoxy)methyl]- ]-4-(2-chloro-phenyl)-6-methyl-1,4-dihydro-pyridine-3,5-dicarboxilic acid –3-ethyl ester 5- methyl ester, compound with benzonesulfonic acid. The hydrochlorothiazide, USP component of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is chemically described as 6-Chloro-3,4 dihydro- 2H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. The structural formula for olmesartan medoxomil, USP is: C 29 H 30 N 6 O 6 M.W. 558.59 The structural formula for amlodipine besylate, USP is: C 20 H 25 ClN 2 O 5 • C 6 H 6 O 3 S M.W. 567.1 The structural formula for hydrochlorothiazide, USP is: C 7 H 8 ClN 3 O 4 S 2 M.W. 297.74 Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, a white to off-white crystalline powder, amlodipine besylate, USP, a white or almost white powder, and hydrochlorothiazide, USP, a white or practically white, practically odorless crystalline powder. Olmesartan medoxomil, USP is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate, USP is sparingly soluble in ethanol, slightly soluble in water and 2-propanol and freely soluble in methanol. Hydrochlorothiazide, USP is slightly soluble in water, freely soluble in hydroxide solution, in n-butylamine and in dimethylformamide (DMF), sparingly soluble in methanol and insoluble in ether, in chloroform and in dilute mineral acids. Each olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablet also contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol (part hydrolyzed), povidone, silicon dioxide, sodium starch glycolate, talc, and titanium dioxide. In addition: 20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg strengths contain FD&C red #40 aluminum lake and iron oxide black, 40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg strengths contain FD&C yellow #6 aluminum lake, 40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg strengths contain D&C yellow #10 aluminum lake, 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg , and 40 mg/5 mg/25 mg strengths contain iron oxide yellow. Structural formula for olmesartan medoxomil. Structural formula for amlodipine besylate. Structural formula for hydrochlorothiazide.

Oseltamivir phosphate for oral suspension, an influenza neuraminidase inhibitor (NAI), is available as: A powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. The tutti-frutti flavoring contains artificial flavors, benzyl alcohol, dl-alpha-tocopherol, maltodextrin, and propylene glycol. Oseltamivir phosphate, USP is a white to off-white powder with the chemical name [3 R -(3α,4β,5α)]-Ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The structural formula is as follows: C 16 H 28 N 2 O 4 •H 3 PO 4 M.W. 410.40 structure

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative consisting of 6 pouches (2 of Pouch A, 2 of Pouch B and 2 of Lemon Flavor Pack) containing white to yellow free flowing powder with odor of lemon for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP. Pouch A contains 111.2 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP. Pouch B contains 10.6 g of powder for oral solution. Each Lemon Flavor pack contains natural lemon flavor; maltodextrin and saccharin sodium. When 1 Pouch A, 1 Pouch B and 1 Lemon Flavor pack are dissolved together in water to a volume of 1 liter, PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution colon preparation contains 200 grams of PEG-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: sodium saccharin, USP, maltodextrin, NF, and lemon flavoring. A mixing container for reconstitution is enclosed.

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

Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Each Penicillin V Potassium Tablet, USP contains penicillin V potassium equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate. Each Penicillin V Potassium Tablet USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each Penicillin V Potassium Tablet USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium. Penicillin V Potassium for Oral Solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V. The inactive ingredients present are cherry flavor, FD&C Red #40, saccharin sodium, sodium benzoate, and sucrose. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted Penicillin V Potassium for Oral Solution USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium. Monopotassium (2 S, 5 R, 6 R )-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. penicillin V potassium structural formula

Pioglitazone Tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo . No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown: C 19 H 20 N 2 O 3 S•HCl M.W. 392.90 Pioglitazone hydrochloride, USP is an odorless white crystalline powder. It is soluble in N , N -dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets USP are available for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, magnesium stearate, and mannitol. Chemical structure

Piroxicam capsules, USP are a nonsteroidal anti-inflammatory drug, available as dark green and olive 10 mg capsules and dark green 20 mg capsules, for oral administration. The chemical name is 4-hydroxyl-2-methyl- N -2-pyridinyl-2 H -1,2,-benzothiazine-3-carboxamide 1,1-dioxide. It has the following structural formula: C 15 H 13 N 3 O 4 S M.W. 331.35 Piroxicam, USP occurs as an off-white to light tan or light yellow powder, sparingly soluble in water, dilute acid, and most organic solvents. It is slightly soluble in alcohol and in aqueous alkaline solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The inactive ingredients in piroxicam capsules, USP include: colloidal silicon dioxide, corn starch, D&C Yellow No. 10, FD&C Green No. 3, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and titanium dioxide. The imprinting ink contains propylene glycol, shellac and titanium dioxide. The 10 mg capsule also contains: ammonium hydroxide, black iron oxide, FD&C Blue No. 1, simethicone (which contains dimethicone and silicon dioxide), and yellow iron oxide. chemical-structure.jpg

Portia ® (levonorgestrel and ethinyl estradiol tablets USP) is a combination oral contraceptive (COC) consisting of 21 pink active tablets, each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 30 mcg of ethinyl estradiol, USP, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel, USP C 21 H 28 O 2 M.W. 312.45 Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,(17α)-(-)-. Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each pink active tablet contains the following inactive ingredients: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The ingredients in the film-coating include FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide. Each white inert tablet contains the following inactive ingredients: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. Levonorgestrel Structure Ethinyl Estradiol Structure

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, [1 S - [1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula: C 23 H 35 NaO 7 M.W. 446.52 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 10 mg, 20 mg and 40 mg pravastatin sodium USP, which is equivalent to 9.50 mg, 19.01 mg and 38.03 mg of pravastatin, respectively. Inactive ingredients include: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone and sodium stearyl fumarate. Additionally, the 10 mg tablet contains ferric oxide red; the 20 mg tablet contains ferric oxide yellow; and the 40 mg tablet contains FD&C Blue No. 1 Aluminum Lake and D&C Yellow No.10. pravastatin sodium structural formula

Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: C 19 H 21 N 5 O 4 •HCl M.W. 419.87 It is a white, crystalline substance, slightly soluble in water and isotonic saline. Each capsule for oral administration, contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inactive ingredients include: anhydrous lactose, magnesium stearate, and pregelatinized starch. Additional inactive ingredients for the gelatin capsule include: 1 mg (Ivory): D&C Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C Red No. 40, D&C Red No. 28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 and titanium dioxide. prazosin hydrochloride capsules structural formula

PROGLYCEM ® (diazoxide) oral suspension is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. PROGLYCEM oral suspension contains 50 mg of diazoxide in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.25%. Other ingredients include sorbitol solution, chocolate cream flavor, propylene glycol, magnesium aluminum silicate, carboxymethylcellulose sodium, mint flavor, sodium benzoate, methylparaben, poloxamer 188, propylparaben, and purified water. Hydrochloric acid or sodium hydroxide may be added to adjust pH. Diazoxide has the following structural formula: Diazoxide is 7-chloro-3-methyl-2 H -1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C 8 H 7 ClN 2 O 2 S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water. Chemical Structure

Quetiapine tablets, USP are an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. The structural formula is: C 42 H 50 N 6 O 4 S 2 •C 4 H 4 O 4 M.W. 883.11 (fumarate salt) Quetiapine fumarate, USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP are supplied for oral administration as 25 mg (round, light orange), 50 mg (round, white to off-white), 100 mg (round, light orange), 200 mg (round, white to off-white), 300 mg (capsule-shaped, pale yellow), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide and triacetin. Additionally, the 25 mg, 100 mg, and 300 mg tablets contain iron oxide yellow; the 25 mg and 100 mg tablets contain FD&C Yellow No. 6/Sunset Yellow FCF Aluminum Lake; and the 50 mg, 200 mg, and 400 mg tablets contain polydextrose and polyethylene glycol. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate, USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.57 mg of quetiapine fumarate, USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.15 mg of quetiapine fumarate, USP equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.30 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.45 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.60 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. quetiapine fumarate structural formula

Quinine sulfate, USP is a cinchona alkaloid chemically described as bis[( R )-(6-methoxyquinolin-4-yl)-[2 S ,4 S ,5 R )-5-ethenyl-1-azabicyclo[2.2.2]oct-2-yl]methanol] sulfate. The structural formula of quinine sulfate, USP is: C 40 H 50 N 4 O 8 S•2H 2 O M.W. 783.0 Quinine sulfate, USP occurs as a white or almost white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is slightly soluble in water, sparingly soluble in boiling water and in alcohol, and practically insoluble in ether. Quinine Sulfate Capsules USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate, USP equivalent to 269 mg free base. Inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. FDA approved dissolution test specifications differ from USP. quinine sulfate structural formula

Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is: C 28 H 27 NO 4 S•HCl M.W. 510.04 The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[ b ]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each Raloxifene Hydrochloride Tablet, USP contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, and titanium dioxide. Product meets USP Dissolution Test 2. 2

Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is C 12 H 13 N•CH 4 SO 3 and its molecular weight is 267.34. Its structural formula is: Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate). Each rasagiline tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid, and talc. structure

Reclipsen™ (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E. Reclipsen blister cards also contain 7 white “inactive” tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Desogestrel C 22 H 30 O M.W. 310.48 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 The 21 rose-colored tablets meet USP Dissolution Test 2. structural formula 1 structural formula 2

Risedronate Sodium Tablets, USP are a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each Risedronate Sodium Tablet, USP for oral administration contains the equivalent of 5, 30, or 35 mg of anhydrous risedronate sodium, USP in the form of the monohydrate. The chemical name of risedronate sodium, USP is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] monosodium salt. The chemical structure of risedronate sodium monohydrate, USP is the following: C 7 H 10 NO 7 P 2 Na•H 2 O M.W. Monohydrate: 323.10 Anhydrous: 305.10 Risedronate sodium monohydrate, USP is a white to off-white powder. It is soluble in water and in aqueous solutions, and essentially insoluble in common organic solvents. Inactive Ingredients Colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized corn starch, sodium stearyl fumarate, and titanium dioxide. Additionally, the 5 mg tablets contain D&C yellow #10 lake, iron oxide yellow, and polysorbate 80; the 30 mg tablets contain polysorbate 80; and the 35 mg tablets contain FD&C yellow #6 aluminum lake, iron oxide yellow, iron oxide red, and polysorbate 80. chemical structure

RIVELSA (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets is an extended-cycle oral contraceptive. RIVELSA consists of 42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-(17α)-(-)-. Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each light pink tablet contains the following inactive ingredients: anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide, and triacetin. Each pink tablet contains the following inactive ingredients: anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin. Each purple tablet contains the following inactive ingredients: anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 1/Brilliant Blue FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C Yellow no. 10 aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol/macrogol, polysorbate 80 and titanium dioxide. levonorgestril structure ethinyl estradiol structure

Rizatriptan Benzoate Tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N , N -dimethyl-5-(1 H -1,2,4-triazol-1-ylmethyl)-1 H -indole-3-ethanamine monobenzoate and its structural formula is: C 15 H 19 N 5 •C 7 H 6 O 2 M.W. 391.47 The molecular weight of the free base is 269.4. Rizatriptan benzoate, USP is a white to almost white, crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Tablets USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. rizatriptan benzoate structural formula

Ustekinumab-aekn, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aekn is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aekn is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. SELARSDI (ustekinumab-aekn) injection is a sterile, preservative-free, clear and colorless to slightly yellow solution free of visible particles with pH of 5.7 to 6.3. SELARSDI for Subcutaneous Use Available as 45 mg of ustekinumab-aekn in 0.5 mL and 90 mg of ustekinumab-aekn in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29-gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-aekn in 0.5 mL in a single-dose borosilicate Type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aekn, histidine (0.122 mg), L-histidine monohydrochloride monohydrate (0.507 mg), polysorbate 80 (0.02 mg), sucrose (38 mg) and water for injection (q.s). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aekn, histidine (0.243 mg), L-histidine monohydrochloride monohydrate (1.013 mg), polysorbate 80 (0.04 mg), sucrose (76 mg) and water for injection (q.s). SELARSDI for Intravenous Infusion Available as 130 mg of ustekinumab-aekn in 26 mL, supplied as a single-dose borosilicate type I glass vial with a rubber stopper. Not made with natural rubber latex. Each 26 mL vial delivers 130 mg ustekinumab-aekn, edetate disodium (0.47 mg), histidine (20.02 mg), L- histidine monohydrochloride monohydrate (27.04 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), sucrose (2,210 mg), and water for injection (q.s).

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