amneal pharmaceuticals ny llc - Medication Listings

Use(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body areas)  this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Difluprednate ophthalmic emulsion, 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is (6α,11β)-21-(Acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)pregna-1,4-diene-3,20-dione. Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.55, and the molecular formula is C 27 H 34 F 2 O 7 . Difluprednate (micronized) is a white to creamy-white crystalline powder. It is freely soluble in acetonitrile and in chloroform, soluble in methanol, in ethanol and in dioxane; slightly soluble in ether; practically insoluble in water. Each mL contains: Active : difluprednate 0.5 mg (0.05%) Inactive : boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsmol/kg Preservative : sorbic acid 0.1% 1

Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( 0 -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1→4)- 0 -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo -hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41 H 64 O 14 , its molecular weight is 780.95, and its structural formula is: Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. digoxin-molec-struc

Dimethyl fumarate delayed-released capsules, USP contain dimethyl fumarate, USP which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ). It has the following structure: Dimethyl fumarate, USP is a white to off-white powder. It is soluble in dichloromethane, N, N dimethyl formamide and sparingly soluble in methanol. Dimethyl fumarate delayed-released capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate, USP consisting of the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, methacrylic acid copolymer Type A, methacrylic acid copolymer dispersion Type C, microcrystalline cellulose, silicified microcrystalline cellulose (microcrystaline cellulose & colloidal silicon dioxide), talc and triethyl citrate. The hard gelatin capsule shells contain: D&C yellow No. 10, FD&C blue No. 1, gelatin, sodium lauryl sulfate and titanium dioxide. Each capsule shell is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze. 10

Doxepin hydrochloride (HCl) cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride, USP (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[ b,e ]oxepin-Δ 11(6H),γ - propylaminehydrochloride. Doxepin hydrochloride, USP has an empirical formula of C 19 H 21 NO•HCl and a molecular weight of 315.84. Doxepin HCl cream, 5% also contains sorbitol solution, cetyl alcohol, isopropyl myristate, glyceryl monostearate, PEG-100 stearate, white petrolatum, benzyl alcohol, titanium dioxide and purified water. Structural Formula

Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO • HCl having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower alcohols and chloroform. It may be represented by the following structural formula: Chemically, doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of 1-Propanamine, 3-dibenz[ b , e ]oxepin-11 (6 H )ylidene- N , N -dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule, USP for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The hard gelatin capsule shells contain D&C Yellow No. 10, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 75 mg and 100 mg hard gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2. formula

Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is with a molecular formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Structural Formula

Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is with a molecular formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C 22 H 24 N 2 O 8 •HCl) 2 •C 2 H 6 O•H 2 O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Structural Formula

Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25 H 22 N 4 O 4 • 2(C 2 H 7 NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating: D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide. structure

Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C 25 H 22 N 4 O 4 • 2(C 2 H 7 NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating: D&C red no. 27 (25 mg tablet), D&C yellow no. 10 (25 mg tablet), FD&C blue no. 1 (25 mg and 50 mg tablet), FD&C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide. Structural Formula

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of emtricitabine (FTC) is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine (FTC) is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24 g/mol. It has the following structural formula: Emtricitabine (FTC) is a white to almost white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 ᵒ C. The partition coefficient (log p) for emtricitabine is −0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.52 g/mol. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 13.4 mg/mL in water at 25 ᵒ C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths: Film-coated tablet containing 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. Emtricitabine and tenofovir disoproxil fumarate tablets also include the following inactive ingredients: calcium stearate, croscarmellose sodium, hypromellose, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. 10 10

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of emtricitabine (FTC) is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine (FTC) is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24 g/mol. It has the following structural formula: Emtricitabine (FTC) is a white to almost white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 ᵒ C. The partition coefficient (log p) for emtricitabine is −0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.52 g/mol. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 13.4 mg/mL in water at 25 ᵒ C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths: Film-coated tablet containing 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. Film-coated tablet containing 167 mg of emtricitabine (FTC) and 250 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients. Film-coated tablet containing 133 mg of emtricitabine (FTC) and 200 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients. Film-coated tablet containing 100 mg of emtricitabine (FTC) and 150 mg of tenofovir disoproxil fumarate (TDF) (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients. Emtricitabine and tenofovir disoproxil fumarate tablets also include the following inactive ingredients: calcium stearate, croscarmellose sodium, hypromellose, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. 10 10

Enalapril maleate oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C 20 H 28 N 2 O 5 •C 4 H 4 O 4 , and its structural formula is: Enalapril maleate is a white to off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include citric acid, mixed berry flavor, purified water, sodium benzoate, sodium citrate, and sucralose. It may also contain hydrochloric acid or sodium hydroxide for pH adjustment. Enalapril maleate oral solution is clear and colorless. Structural Formula

Enalapril maleate (enalapril maleate) oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C 20 H 28 N 2 O 5 •C 4 H 4 O 4 , and its structural formula is: Enalapril maleate is an off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include artificial juicy raspberry flavor, malic acid, purified water, sodium benzoate, and sucralose. Enalapril maleate oral solution is clear and colorless. Structural Formula

Erythromycin delayed-release tablets, USP are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets, USP for oral administration are available in three dosage strengths, each white to off white, oval shaped tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin, USP is a white or slightly yellow powder or colorless or slightly yellow crystals. It is soluble in alcohol, in chloroform and in ether, slightly soluble in water. Erythromycin, USP is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihdroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6trideoxy-3-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C 37 H 67 NO 13 , and the molecular weight is 733.94. The structural formula is: Inactive Ingredients Croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, silicon dioxide, sodium citrate, sodium hydroxide, sorbitan monooleate, talc and titanium dioxide. Meets USP Dissolution Test 3. structure

Erythromycin, USP is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate, USP is an ester of erythromycin, USP suitable for oral administration. Erythromycin ethylsuccinate, USP is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C 43 H 75 NO 16 and the molecular weight is 862.05 g/mol. The structural formula is: Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate, USP equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing fruit flavor. Erythromycin ethylsuccinate for oral suspension, USP, 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate, USP equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL contains caramel flavor, mixed fruit flavor, polysorbate 80, sodium citrate dihydrate, sucrose, and xanthan gum. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL contains banana flavor, caramel flavor, polysorbate 80, sodium citrate dihydrate, sucrose, and xanthan gum. 1

Erythromycin, USP is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate, USP is an ester of erythromycin, USP suitable for oral administration. Erythromycin ethylsuccinate, USP is known chemically as erythromycin 2′-(ethyl succinate). The molecular formula is C 43 H 75 NO 16 and the molecular weight is 862.06. The structural formula is: Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate, USP equivalent to 200 mg erythromycin, USP per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing fruit flavor. Erythromycin ethylsuccinate for oral suspension, USP, 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate, USP equivalent to 400 mg of erythromycin, USP per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL contains caramel flavor, mixed fruit flavor, polysorbate 80, sodium citrate dihydrate, sucrose, and xanthan gum. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL contains banana flavor, caramel flavor, polysorbate 80, sodium citrate dihydrate, sucrose, and xanthan gum. Formula structure

Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6. formula 3 layers

Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm 2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is: The molecular formula of estradiol, USP is C 18 H 24 0 2 . The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP. Structural Formula Active Component System

Estradiol gel 0.1%, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol, USP when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1, and 1.25 mg estradiol USP, respectively). The active component of the topical gel is estradiol USP, an estrogen. Estradiol, USP is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The remaining components of the gel (carbomer homopolymer type B, ethyl alcohol 95%, propylene glycol, purified water, and trolamine) are pharmacologically inactive. Estradiol gel, 0.1% contains 55% w/w alcohol. Structural Formula

Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2, 3-dichloro-4-(2-methylene-1-oxobutyl) phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid, USP is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13 H 12 Cl 2 O 4 and its structural formula is: Ethacrynic acid tablets, USP are supplied as 25 mg tablets for oral use. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. structure

Etodolac is member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac, USP for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac, USP is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac, USP. In addition, each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. Each 400 mg tablet also contains iron oxide red and iron oxide yellow. Each 500 mg tablet also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. formula

Etravirine, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl) amino]-4-pyrimidinyl] oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C 20 H 15 BrN 6 O and its molecular weight is 435.28 g/mol. Etravirine has the following structural formula: Etravirine, USP is a white to slightly yellowish-brown powder. Etravirine, USP is practically insoluble in water and freely soluble in some organic solvents like N,N-dimethylformamide and tetrahydrofuran. Etravirine tablets, USP are for oral administration. Each etravirine tablet, USP contains 25 mg, 100 mg or 200 mg of etravirine, USP. It also contains the inactive ingredients: croscarmellose sodium, crospovidone (type A), colloidal silicon dioxide, hypromellose, low-substituted hydroxy propyl cellulose, magnesium stearate and microcrystalline cellulose. chemical structure

Everolimus tablets for oral suspension are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.0 4,9 ]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53 H 83 NO 14 and the molecular weight is 958.22 g/mol. The structural formula is: Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone Type-A, hypromellose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. 01

Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4- fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe tablets, USP are available as a tablet for oral use containing 10 mg of ezetimibe, USP and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate. structure

Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24 H 21 F 2 NO 3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is: Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,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 ester, [1 S -[1α,3α,7β,8β(2 S * ,4 S * ),-8aβ]]. The molecular formula of simvastatin is C 25 H 38 O 5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is: Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate. 1 2

The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine, USP is propanimidamide, N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-. The empirical formula of famotidine, USP is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: citric acid monohydrate, flavors (cherry, banana, and peppermint), powdered cellulose, sucrose and xanthan gum. Added as preservatives are sodium benzoate 0.1%, methylparaben sodium 0.1% and propylparaben sodium 0.02%. Famotidine, USP is a white to pale yellowish white crystalline compound that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. 1

The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine, USP is propanimidamide, N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-. The empirical formula of famotidine, USP is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: citric acid monohydrate, flavors (cherry, banana, and peppermint), powdered cellulose, sucrose and xanthan gum. Added as preservatives are sodium benzoate 0.1%, methylparaben sodium 0.1% and propylparaben sodium 0.02%. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Structural Formula

Femynor™ (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each red “active” tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide. Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide. norgestimate formula ethinyl estradiol

Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83 g/mol; fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, NF; hypromellose, USP; magnesium stearate, NF; and microcrystalline cellulose, NF. The film-coating material contains hypromellose, macrogol, polydextrose, titanium dioxide and triacetin. In addition, the 54 mg strength film-coating material also contains D&C Yellow No. 10 Aluminum Lake and FD&C Yellow # 6/Sunset yellow FCF aluminum lake. 1

Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains crospovidone, hypromellose, lactose monohydrate, lecithin, magnesium stearate, silicified microcrystalline cellulose, sodium benzoate, sodium lauryl sulfate, and sucrose. In addition, individual tablets contain: 48 mg tablets: D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. 145 mg tablets: Polyethylene glycol, polyvinyl alcohol, titanium dioxide, and talc. formula

Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each 54 mg fenofibrate tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, D&C yellow #10 aluminum lake, FD&C Yellow # 6/Sunset yellow FCF aluminum lake, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, simethicone, sodium benzoate, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide. Each 160 mg fenofibrate tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, simethicone, sodium benzoate, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide. Fenofibrate meets USP Dissolution Test 2. 11

Fludrocortisone acetate tablets USP, 0.1 mg contain fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity; it is used only for its mineralocorticoid effects. The chemical name for fludrocortisone acetate is 9-fluoro-11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione 21-acetate; its structural formula is: C 23 H 31 FO 6 MW 422.49 Fludrocortisone acetate tablets USP, 0.1 mg are available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, and microcrystalline cellulose NF. Chemical Structure

Fluocinonide Cream USP, 0.05% is intended for topical administration. The active component in each is the corticosteroid fluocinonide, USP, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy) -6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6a,11b,16a)-. It has the following chemical structure: Fluocinonide Cream USP, 0.05% contains fluocinonide, USP 0.5 mg/g in a specially formulated cream base consisting of citric acid monohydrate, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol- 8000, propylene glycol and stearyl alcohol. This white cream is greaseless and free from any foreign particles, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In the Fluocinonide Cream USP, 0.05% the active ingredient is totally in solution. formula

Fluorometholone Ophthalmic Suspension USP, 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Fluorometholone, USP is practically white crystalline powder. It is practically insoluble in water, slightly soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether. Chemical name: 9-Fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Structural formula: Molecular weight: 376.5 g/mol Molecular formula: C 22 H 29 FO 4 Each mL of fluorometholone ophthalmic suspension USP, 0.1% contains: Active: Fluorometholone USP, 0.1% (1 mg). Preservative: Benzalkonium chloride, 0.004% (0.04 mg). Inactives: Edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; water for injection; sodium chloride; sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate; and sodium hydroxide to adjust pH. Fluoromethonolone ophthamic suspension, USP is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290 mOsm/kg to 350 mOsm/kg. struc

Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Chemically it is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl]propyl]-1-piperazineethanol dihydrochloride which may be represented by the following structural formula: Molecular Formula: C 22 H 26 F 3 N 3 OS.2HCl Molecular Weight: 510.44 g/mol. Fluphenazine hydrochloride, USP is a white or nearly white, crystalline powder. It is soluble in water, and practically insoluble in acetone, methylene chloride and in chloroform. Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, or 10 mg of fluphenazine hydrochloride, USP per tablet. Inactive ingredients are: anhydrous lactose granulated, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium lauryl sulphate and titanium dioxide. The following coloring agents are employed: 2.5 mg – iron oxide yellow 5 mg – FD&C blue No. 1, iron oxide yellow 10 mg – iron oxide red, iron oxide yellow. Meets USP Dissolution Test 2. qwerty

Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a white to off-white powder in a single-dose sachet. Each 8 grams granules per sachet contains 5.631 grams of fosfomycin tromethamine, USP (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1 R ,2 S )-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). Fosfomycin tromethamine, USP is a white or almost white powder. It is very soluble in water, slightly soluble in ethanol (96 %) and in methanol, practically insoluble in acetone. The molecular weight of fosfomycin tromethamine is 259.2 g/mol, molecular formula is C 3 H 7 O 4 P.C 4 H 11 NO 3 , and its chemical structure is as follows: 1

Frovatriptan succinate tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine 1 (5-HT 1B/1D ) receptor subtype agonist (triptan), as the active ingredient. Frovatriptan succinate is chemically designated as R-(+) 3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole monosuccinate monohydrate and it has the following structure: The molecular formula is C 18 H 23 N 3 O 5 .H 2 O, representing a molecular weight of 379.4 g/mol. Frovatriptan succinate is a white to off-white powder that is soluble in water. Each frovatriptan succinate tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains following inactive ingredients: anhydrous lactose, hypromellose, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, titanium dioxide and triacetin. 10

Hydroxychloroquine sulfate, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C 18 H 26 C l N 3 O•H 2 SO 4 . The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is: Hydroxychloroquine sulfate, USP is a white to almost white crystalline powder. It is freely soluble in water; practically insoluble in ethanol (96%) and in ether. Hydroxychloroquine sulfate tablets USP, 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base) and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, maize starch, magnesium stearate, polyvinyl alcohol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide. Meets USP Dissolution Test 2. 1

Hydroxychloroquine sulfate, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C 18 H 26 ClN 3 O•H 2 SO 4 . The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is: Hydroxychloroquine sulfate, USP is a white to almost white crystalline powder. It is freely soluble in water; practically insoluble in ethanol (96%) and in ether. Hydroxychloroquine sulfate tablets USP, 200 mg for oral administration contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base) and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, maize starch, magnesium stearate, polyvinyl alcohol, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide. Meets USP Dissolution Test 2. 12

Indomethacin suppositories, USP are a nonsteroidal anti-inflammatory drug, available as a suppository containing 50 mg of indomethacin, USP administered for rectal use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin, USP is a pale yellow to yellow-tan crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin suppositories, USP include: butylated hydroxyanisole, butylated hydroxytoluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000, purified water and sodium chloride. Indomethacin suppositories, USP 50 mg each, are yellow to white, opaque, rectal suppositories. FDA approved drug product storage condition and dissolution specifications differs from the USP. Structural Formula

The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate, (endo, syn)-, (+)-, a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: C 20 H 30 BrNO 3 •H 2 O ipratropium bromide, USP Mol. Wt. 430.4 Ipratropium bromide, USP is a white or almost white crystalline substance, freely soluble in methanol, soluble in water, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 μL) in an isotonic, aqueous solution with pH adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 345 sprays. Structural Formula

The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide, USP (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate ( endo,syn )-, (±)-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: C 20 H 30 BrNO 3 •H 2 O ipratropium bromide, USP Mol. Wt. 430.4 Ipratropium bromide, USP is a white or almost white crystalline substance, freely soluble in methanol, soluble in water, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide, USP (on an anhydrous basis) per spray (70 μL) in an isotonic, aqueous solution with pH-adjusted to 4.7. It also contains benzalkonium chloride, edetate disodium, sodium chloride, sodium hydroxide, hydrochloric acid, and purified water. Each bottle contains 165 sprays. Structural Formula

Isotretinoin Capsules, USP Isotretinoin capsules, USP contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin, USP (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin USP, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems: 10 mg – D&C yellow #10, FD&C yellow #6, FD&C red #40, FD&C blue #1 and titanium dioxide 20 mg – iron oxide (red), FD&C red #40, FD&C blue #1 and titanium dioxide 25 mg – FD&C Yellow #6, FD&C blue #1 and titanium dioxide 30 mg – D&C yellow #10, FD&C red #40, FD&C blue #1 and titanium dioxide 35 mg – FD&C Yellow #6, FD&C red #40, FD&C Blue #1 and titanium dioxide 40 mg – iron oxide (black, red and yellow), FD&C red #40, FD&C Blue #1 and titanium dioxide The black imprinting ink of 10 mg and 20 mg capsules contains the following ingredients: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution (strong ammonia solution), iron oxide (black), potassium hydroxide and purified water. The white imprinting ink of 25 mg, 30 mg, 35 mg and 40 mg capsules contains the following ingredients: shellac, titanium dioxide, isopropyl alcohol, ammonia solution (ammonium hydroxide), propylene glycol, butyl alcohol (n-Butyl alcohol) and simethicone. Isotretinoin, USP Chemically, isotretinoin, USP is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is: FDA approved dissolution test specifications differ from USP. Structural Formula

Isotretinoin USP, a retinoid, is available in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder. The structural formula is: C 20 H 28 O 2 Molecular Weight: 300.44 Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide, and white wax (beeswax). In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake. Product meets USP Dissolution Test 4. chem structure

Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure: The molecular formula for lenalidomide dimethyl sulphoxide is C 13 H 13 N 3 O 3 .½ (C 2 H 6 OS), and the gram molecular weight is 298.33. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. 1

Lopreeza 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose and triacetin. Lopreeza 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), hydroxypropylcellulose, talc, magnesium stearate, hypromellose and triacetin. Estradiol is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol hemihydrate with the empirical formula of C 18 H 24 O 2 ,1/2 H 2 O and a molecular weight of 281.4. The structural formula of E 2 is as follows: Estradiol Norethindrone acetate (NETA) is a white or yellowish-white crystalline powder. Its chemical name is 17β -acetoxy-19-nor-17α -pregn-4-en-20-yn-3-one with the empirical formula of C 22 H 28 O 3 and molecular weight of 340.5. The structural formula of NETA is as follows: Norethindrone Acetate Estradiol structural formula Norethindrone Acetate structural formula

Lopreeza 1 mg/0.5 mg is a single tablet for oral administration containing 1 mg of estradiol and 0.5 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), copovidone, talc, magnesium stearate, hypromellose and triacetin. Lopreeza 0.5 mg/0.1 mg is a single tablet for oral administration containing 0.5 mg of estradiol and 0.1 mg of norethindrone acetate and the following excipients: lactose monohydrate, starch (corn), hydroxypropylcellulose, talc, magnesium stearate, hypromellose and triacetin. 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 with the empirical formula of C 18 H 24 O 2 ,½ H 2 O and a molecular weight of 281.4. The structural formula of E 2 is as follows: Estradiol 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 with the empirical formula of C 22 H 28 O 3 and molecular weight of 340.5. The structural formula of NETA is as follows: Norethindrone Acetate estradiol chem structure noreth acetate chem structure

Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white crystalline powder. Loteprednol etabonate is represented by the following structural formula: Molecular formula: C 24 H 31 ClO 7 Molecular weight: 466.95 g/mol Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains: ACTIVE: Loteprednol Etabonate, 5 mg (0.5%) INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 3.5 to 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride, 0.01%. 00

Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a micronized sterile white to off-white crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Loteprednol etabonate is represented by the following structural formula: Molecular formula: C 24 H 31 ClO 7 Molecular weight: 466.95 g/mol Chemical name: Chloromethyl 11β, 17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate, 17-(ethyl carbonate). Each mL of Loteprednol etabonate ophthalmic suspension, 0.2% contains: ACTIVE: Loteprednol etabonate, 2 mg (0.2%) PRESERVATIVE ADDED: Benzalkonium chloride, 0.01% INACTIVES: Edetate disodium, glycerin, povidone K90, tyloxapol and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH between 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. 1