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    Chemistry

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    Also known as: 595-33-5, Megace, Megace es, Niagestin, Megestryl acetate, Megeron
    Molecular Formula
    C24H32O4
    Molecular Weight
    384.5  g/mol
    InChI Key
    RQZAXGRLVPAYTJ-GQFGMJRRSA-N
    FDA UNII
    TJ2M0FR8ES
    Megestrol Acetate
    Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
    1 2D Structure

    Megestrol Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(8R,9S,10R,13S,14S,17R)-17-acetyl-6,10,13-trimethyl-3-oxo-2,8,9,11,12,14,15,16-octahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate
    2.1.2 InChI
    InChI=1S/C24H32O4/c1-14-12-18-19(22(4)9-6-17(27)13-21(14)22)7-10-23(5)20(18)8-11-24(23,15(2)25)28-16(3)26/h12-13,18-20H,6-11H2,1-5H3/t18-,19+,20+,22-,23+,24+/m1/s1
    2.1.3 InChI Key
    RQZAXGRLVPAYTJ-GQFGMJRRSA-N
    2.1.4 Canonical SMILES
    CC1=CC2C(CCC3(C2CCC3(C(=O)C)OC(=O)C)C)C4(C1=CC(=O)CC4)C
    2.1.5 Isomeric SMILES
    CC1=C[C@@H]2[C@H](CC[C@]3([C@H]2CC[C@@]3(C(=O)C)OC(=O)C)C)[C@@]4(C1=CC(=O)CC4)C
    2.2 Other Identifiers
    2.2.1 UNII
    TJ2M0FR8ES
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acetate, Megestrol

    2. Apo Megestrol

    3. Apo-megestrol

    4. Apomegestrol

    5. Borea

    6. Lin Megestrol

    7. Lin-megestrol

    8. Linmegestrol

    9. Maygace

    10. Megace

    11. Megefren

    12. Megestat

    13. Megostat

    14. Mestrel

    15. Nu Megestrol

    16. Nu-megestrol

    17. Numegestrol

    2.3.2 Depositor-Supplied Synonyms

    1. 595-33-5

    2. Megace

    3. Megace Es

    4. Niagestin

    5. Megestryl Acetate

    6. Megeron

    7. Megestat

    8. Ovaban

    9. Ovarid

    10. Maygace

    11. Pallace

    12. Bdh 1298

    13. Magestin

    14. Sc 10363

    15. Nsc-71423

    16. Volidan

    17. Sc10363

    18. 17alpha-hydroxy-6-methylpregna-4,6-diene-3,20-dione Acetate

    19. Megesterol Acetate

    20. 17alpha-acetoxy-6-dehydro-6-methylprogesterone

    21. 6-dehydro-6-methyl-17alpha-acetoxyprogesterone

    22. 6-methyl-6-dehydro-17alpha-acetoxyprogesterone

    23. 17-hydroxy-6-methylpregna-4,6-diene-3,20-dione 17-acetate

    24. 17-acetoxy-6-methylpregna-4,6-diene-3,20-dione

    25. Sc-10363

    26. 17-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione

    27. Bdh-1298

    28. 6-methyl-17alpha-hydroxy-delta(sup 6)-progesterone Acetate

    29. Tj2m0fr8es

    30. [(8r,9s,10r,13s,14s,17r)-17-acetyl-6,10,13-trimethyl-3-oxo-2,8,9,11,12,14,15,16-octahydro-1h-cyclopenta[a]phenanthren-17-yl] Acetate

    31. Pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-

    32. 6-methyl-3,20-dioxopregna-4,6-dien-17-yl Acetate

    33. Megestrol 17.alpha.-acetate

    34. Mls000028633

    35. 17-hydroxy-6-methylpregna-4,6-diene-3,20-dione Acetate

    36. Bdh1298

    37. Smr000058691

    38. Dsstox_cid_20683

    39. Dsstox_rid_79539

    40. Dsstox_gsid_40683

    41. Megestil

    42. 6-methyl-17alpha-acetoxypregna-4,6-diene-3,20-dione

    43. Ovaban (veterinary)

    44. 6-methyl-delta(sup 6)-dehydro-17alpha-acetoxyprogesterone

    45. Megestrolacetate

    46. 6-methyl-delta(sup 4,6)-pregnadien-17alpha-ol-3,20-dione Acetate

    47. Megestrol Acetate [usan]

    48. (8xi,9xi,10xi,13xi,14xi)-6-methyl-3,20-dioxopregna-4,6-dien-17-yl Acetate

    49. Ccris 372

    50. Pregna-4,6-diene-3,20-dione, 17-hydroxy-6-methyl-, Acetate

    51. Megestrol-17-acetate

    52. Einecs 209-864-5

    53. Unii-tj2m0fr8es

    54. Megestin

    55. Megestrol Acetole [progestins]

    56. Megestrol Acetate [usan:usp]

    57. Megestrol Acetole

    58. Megestrol-acetate

    59. 17-alpha-acetoxy-6-dehydro-6-methylprogesterone

    60. 6-dehydro-6-methyl-17-alpha-acetoxyprogesterone

    61. 6-methyl-6-dehydro-17-alpha-acetoxyprogesterone

    62. Ncgc00016516-01

    63. (8r,9s,10r,13s,14s,17r)-17-acetyl-6,10,13-trimethyl-3-oxo-2,3,8,9,10,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-17-yl Acetate

    64. Cas-595-33-5

    65. Megace (tn)

    66. 17alpha-acetoxy-6-methylpregna-4,6-diene-3,20-dione

    67. 6-methyl-17-alpha-acetoxypregna-4,6-diene-3,20-dione

    68. 6-methyl-17-alpha-hydroxy-delta(sup 6)-progesterone Acetate

    69. 6-methyl-6-dehydro-17.alpha.-acetylprogesterone

    70. 6-methyl-delta(sup 6)-dehydro-17-alpha-acetoxyprogesterone

    71. 6-methyl-delta4,6-pregnadien-17alpha-ol-3,20-dione Acetate

    72. 17.alpha.-acetoxy-6-dehydro-6-methylprogesterone

    73. 6-dehydro-6-methyl-17.alpha.-acetoxyprogesterone

    74. 6-methyl-6-dehydro-17.alpha.-acetoxyprogesterone

    75. Megestrol Acetate (usp)

    76. Opera_id_1511

    77. Prestwick0_000956

    78. Prestwick1_000956

    79. Prestwick2_000956

    80. Prestwick3_000956

    81. 6-methyl-delta(sup 4,6)-pregnadien-17-alpha-ol-3,20-dione Acetate

    82. Schembl745

    83. Bspbio_000952

    84. Mls000759501

    85. Mls001074091

    86. Mls001424055

    87. Par-100,2

    88. Spbio_003101

    89. Megestrol Acetate [mi]

    90. Bpbio1_001048

    91. Chebi:6723

    92. Chembl1201139

    93. Dtxsid9040683

    94. Megestrol Acetate [vandf]

    95. Megestrol Acetate [mart.]

    96. Bcpp000168

    97. Hms1570p14

    98. Hms2051i20

    99. Hms2090n04

    100. Hms2097p14

    101. Hms2235d16

    102. Hms3714p14

    103. Megestrol Acetate [usp-rs]

    104. Megestrol Acetate [who-dd]

    105. Megestrol Acetate [who-ip]

    106. Nia

    107. Nsc71423

    108. Zinc4097467

    109. Tox21_110469

    110. Tox21_302360

    111. Lmst02030118

    112. Mfcd00056470

    113. S1304

    114. Akos015894927

    115. Megestrol Acetate [green Book]

    116. Tox21_110469_1

    117. Bcp9000904

    118. Ccg-100899

    119. Cs-2065

    120. Db00351

    121. Megestrol Acetate [orange Book]

    122. Nc00149

    123. Megestrol Acetate [ep Monograph]

    124. 17-acetoxy-6-methylpregna-4,20-dione

    125. Megestrol Acetate [usp Monograph]

    126. Ncgc00024196-03

    127. Ncgc00024196-05

    128. Ncgc00255456-01

    129. Ac-24570

    130. As-13384

    131. Hy-13676

    132. 17.alpha.-acetoxy-6-methyl-4,20-dione

    133. Ab00490013

    134. B1377

    135. 17-hydroxy-6-methylpregna-4,20-dione Acetate

    136. 17.alpha.-acetoxy-6-methylpregna-4,20-dione

    137. C08151

    138. D00952

    139. D91560

    140. Ab00383046-13

    141. Ab00383046-14

    142. Ab00383046-15

    143. Ab00383046_16

    144. Pregna-4,20-dione, 17-(acetyloxy)-6-methyl-

    145. 595m335

    146. A832354

    147. Megestrol-17-acetate 1000 Microg/ml In Methanol

    148. Sr-01000000258

    149. Megestrol-17-acetate 100 Microg/ml In Acetonitrile

    150. Pregna-4,20-dione, 17-hydroxy-6-methyl-, Acetate

    151. Q-201346

    152. Q6808975

    153. Sr-01000000258-4

    154. Brd-k19507340-001-03-1

    155. Medroxyprogesterone Acetate Impurity G [who-ip]

    156. Megestrol Acetate, Vetranal(tm), Analytical Standard

    157. Megestrol-17-acetate 100 Microg/ml In Methanol/water

    158. 17alpha-acetoxy-6-methyl-4,6-pregnadiene-3,20-dione

    159. Megestrol Acetate, Analytical Standard, For Drug Analysis

    160. Medroxyprogesterone Acetate Impurity G [ep Impurity]

    161. Wln: L E5 B666 Ov Ku Mutj A1 E1 Fv1 Fov1 L1

    162. 6-methyl-17.alpha.-hydroxy-.delta.(sup 6)-progesterone Acetate

    163. Megestrol Acetate, European Pharmacopoeia (ep) Reference Standard

    164. 6-methyl-3,20-dioxopregna-4,6-dien-17-yl Acetate [who-ip]

    165. Megestrol Acetate, United States Pharmacopeia (usp) Reference Standard

    166. Megesgtrol Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

    167. Megestrol Acetate For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    168. Megestrol Acetate For System Suitability, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 384.5 g/mol
    Molecular Formula C24H32O4
    XLogP33.1
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count3
    Exact Mass384.23005950 g/mol
    Monoisotopic Mass384.23005950 g/mol
    Topological Polar Surface Area60.4 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity821
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameMegace
    PubMed HealthMegestrol Acetate (By mouth)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelMEGACE (megestrol acetate, USP) Oral Suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-(acetyloxy)-6...
    Active IngredientMegestrol acetate
    Dosage FormSuspension
    RouteOral
    Strength40mg/ml
    Market StatusPrescription
    CompanyBristol Myers Squibb

    2 of 6  
    Drug NameMegace es
    PubMed HealthMegestrol Acetate (By mouth)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelMegace ES oral suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methyl pregna-4,6-diene-3...
    Active IngredientMegestrol acetate
    Dosage FormSuspension
    RouteOral
    Strength125mg/ml
    Market StatusPrescription
    CompanyPar Pharm

    3 of 6  
    Drug NameMegestrol acetate
    PubMed HealthMegestrol Acetate (By mouth)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelMegestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37C in water is 2 mcg per mL...
    Active IngredientMegestrol acetate
    Dosage FormTablet; Suspension
    RouteOral
    Strength125mg/ml; 40mg/ml; 40mg; 20mg
    Market StatusPrescription
    CompanyTwi Pharms; Wockhardt; Par Pharm; Roxane; Teva Pharms; Barr

    4 of 6  
    Drug NameMegace
    PubMed HealthMegestrol Acetate (By mouth)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelMEGACE (megestrol acetate, USP) Oral Suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-(acetyloxy)-6...
    Active IngredientMegestrol acetate
    Dosage FormSuspension
    RouteOral
    Strength40mg/ml
    Market StatusPrescription
    CompanyBristol Myers Squibb

    5 of 6  
    Drug NameMegace es
    PubMed HealthMegestrol Acetate (By mouth)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelMegace ES oral suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methyl pregna-4,6-diene-3...
    Active IngredientMegestrol acetate
    Dosage FormSuspension
    RouteOral
    Strength125mg/ml
    Market StatusPrescription
    CompanyPar Pharm

    6 of 6  
    Drug NameMegestrol acetate
    PubMed HealthMegestrol Acetate (By mouth)
    Drug ClassesEndocrine-Metabolic Agent
    Drug LabelMegestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37C in water is 2 mcg per mL...
    Active IngredientMegestrol acetate
    Dosage FormTablet; Suspension
    RouteOral
    Strength125mg/ml; 40mg/ml; 40mg; 20mg
    Market StatusPrescription
    CompanyTwi Pharms; Wockhardt; Par Pharm; Roxane; Teva Pharms; Barr

    4.2 Drug Indication

    For the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Also used for the palliative management of recurrent, inoperable, or metastatic breast cancer, endometrial cancer, and prostate cancer in Canada and some other countries.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Megestrol is a synthetic progestin and has the same physiologic effects as natural progesterone. These effects include induction of secretory changes in the endometrium, increase in basal body temperature, pituitary inhibition, and production of withdrawal bleeding in the presence of estrogen. Mestrogel has slight glucocorticoid activity and very slight mineralocorticoid activity. This drug has no estrogenic, androgenic, or anabolic activity. The precise mechanism of megestrol’s antianorexic and anticachetic effects is unknown. Initially developed as a contraceptive, it was first evaluated in breast cancer treatment in 1967.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents, Hormonal

    Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)

    Appetite Stimulants

    Agents that are used to stimulate appetite. These drugs are frequently used to treat anorexia associated with cancer and AIDS. (See all compounds classified as Appetite Stimulants.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Progestin [EPC]; Progesterone Congeners [CS]
    5.4 Absorption, Distribution and Excretion

    Absorption

    Variable, but well absorbed orally.

    Route of Elimination

    The major route of drug elimination in humans is urine. Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the radioactivity not found in urine and feces.

    5.5 Metabolism/Metabolites

    Primarily hepatic. Megestrol metabolites which were identified in urine constituted 5% to 8% of the dose administered. Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the radioactivity not found in urine and feces. No active metabolites have been identified.

    5.6 Biological Half-Life

    34 hours

    5.7 Mechanism of Action

    The precise mechanism by which megestrol acetate produces effects in anorexia and cachexia is unknown at the present time, but its progestin antitumour activity may involve suppression of luteinizing hormone by inhibition of pituitary function. Studies also suggest that the megestrol's weight gain effect is related to its appetite-stimulant or metabolic effects rather than its glucocorticoid-like effects or the production of edema. It has also been suggested that megestrol may alter metabolic pathyways via interferences with the production or action of mediators such as cachectin, a hormone that inhibits adipocyte lipogenic enzymes.

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    [{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663612200,"product":"NOMEGESTROL ACETATE (BATCH NO.NB1923)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"NEWCHEM SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"VIATRIS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"15677.6","totalValueFC":"15728.3","currency":"USD","unitRateINR":"1260480","date":"20-Sep-2022","totalValueINR":"1260480","totalValueInUsd":"15728.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372300","bill_no":"1003880","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA EDMONDO DE AMICIS 47 20123, M ILANO ITALY. , , Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699468200,"product":"NOMEGESTROL ACETATE (BATCH NO.ND1116)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"NEWCHEM SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"VIATRIS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"16788.6","totalValueFC":"33931.6","currency":"USD","unitRateINR":"1412756.5","date":"09-Nov-2023","totalValueINR":"2825513","totalValueInUsd":"33931.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372300","bill_no":"1004595","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA E.DE AMICIS 47 20123 ITALY 0","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706293800,"product":"NOMEGESTROL ACETATE (BATCH NO.ND1116)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"NEWCHEM SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"VIATRIS","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"14267.5","totalValueFC":"72186","currency":"USD","unitRateINR":"1199900","date":"27-Jan-2024","totalValueINR":"5999500","totalValueInUsd":"72186","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372300","bill_no":"1000339","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA E. DE AMICIS-47 20123 MILANO Italy","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712341800,"product":"NOMEGESTROL ACETATE (BATCH NO.NE0732)","address":"","city":"","supplier":"NEWCHEM SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"SENADOR LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"14186.7","totalValueFC":"71649.4","currency":"USD","unitRateINR":"1196650","date":"06-Apr-2024","totalValueINR":"5983250","totalValueInUsd":"71649.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372300","bill_no":"1001291","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA E. DE AMICIS-47 20123 MILANO Italy","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716316200,"product":"NOMEGESTROL ACETATE (BATCH NO.NE1274)","address":"","city":"","supplier":"NEWCHEM SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"SENADOR LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"14256.1","totalValueFC":"144263.9","currency":"USD","unitRateINR":"1202500","date":"22-May-2024","totalValueINR":"12025000","totalValueInUsd":"144263.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372300","bill_no":"1001855","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA E.DE AMICIS 47 20123 ITALY 0","customerAddress":""}]
    20-Sep-2022
    22-May-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DOSAGE - SUSPENSION;ORAL - 40MG/ML **Federal ...DOSAGE - SUSPENSION;ORAL - 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20264

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    DOSAGE - SUSPENSION;ORAL - 125MG/ML

    USFDA APPLICATION NUMBER - 21778

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