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Also known as: 496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr
Molecular Formula
C29H36N6O6
Molecular Weight
564.6  g/mol
InChI Key
DJMJHIKGMVJYCW-UHFFFAOYSA-N
FDA UNII
4U07F515LG

Eltrombopag
Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.
1 2D Structure

Eltrombopag

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic acid
2.1.2 InChI
InChI=1S/C25H22N4O4.2C2H7NO/c1-14-10-11-19(12-15(14)2)29-24(31)22(16(3)28-29)27-26-21-9-5-8-20(23(21)30)17-6-4-7-18(13-17)25(32)33;2*3-1-2-4/h4-13,28,30H,1-3H3,(H,32,33);2*4H,1-3H2
2.1.3 InChI Key
DJMJHIKGMVJYCW-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C=C(C=C1)N2C(=O)C(=C(N2)C)N=NC3=CC=CC(=C3O)C4=CC(=CC=C4)C(=O)O)C.C(CO)N.C(CO)N
2.2 Other Identifiers
2.2.1 UNII
4U07F515LG
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-

2. Ddl-701

3. Eltrombopag

4. Promacta

5. Revolade

6. Sb-497 115

7. Sb-497-115

8. Sb497115

2.3.2 Depositor-Supplied Synonyms

1. 496775-62-3

2. Revolade

3. Promacta

4. Eltrombopag (olamine)

5. Unii-4u07f515lg

6. Sb-497115-gr

7. Eltrombopag Diethanolamine Salt

8. 496775-62-3 (olamine)

9. Eltrombopag (as Olamine)

10. 4u07f515lg

11. Sb-497115gr

12. Eltrombopag Compd With 2-aminoethanol (1:2)

13. Eltrombopag Diethanolamine Salt;sb-497115gr

14. (z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxyiic Acid;2-aminoethan-1-ol (1:2)

15. 3'-((2z)-2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic Acid Compound With 2-aminoethanol (1:2)

16. Promacta Olamine

17. Eltrombopagolamine

18. Eltrombopag Olamine [usan:jan]

19. Promacta (tn)

20. Sb 497115gr

21. Schembl210183

22. Amy267

23. Chembl3989691

24. Schembl16207741

25. Schembl23458316

26. Eltrombopag Olamine (jan/usan)

27. Eltrombopag Olamine [jan]

28. Eltrombopag Olamine [usan]

29. Bcp07055

30. Eltrombopag Olamine [mart.]

31. Eltrombopag Olamine [who-dd]

32. Hy-15306a

33. Mfcd22380664

34. S2229

35. Akos025396658

36. Akos037515856

37. Ccg-270074

38. Cs-1566

39. Sb19102

40. Eltrombopag Olamine [orange Book]

41. 2-aminoethan-1-ol Hemi((e)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1h-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)

42. Ac-26286

43. Bs-17370

44. Ft-0773802

45. D03978

46. A904098

47. Q27260489

48. Eltrombopag Compd With 2-aminoethanol (1:2) [mi]

49. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, Compound With 2-aminoethanol (1:2)

50. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-, Compound With 2-aminoethanol (1:2)

51. (1,1'-biphenyl)-3-carboxylic Acid, 3'-(2-(1-(3,4-dimethylphenyl)-4,5-dihydro-3-methyl-5-oxo-1h-pyrazol-4-yl)diazenyl)-2'-hydroxy-, Compd. With 2-aminoethanol (1:2)

52. 2-aminoethan-1-ol Hemi((z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate)

53. 2-aminoethanol (e)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-pyrazol-4(5h)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate

54. 2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1h-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic Acid

55. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

56. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

57. 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)

2.4 Create Date
2019-01-15
3 Chemical and Physical Properties
Molecular Weight 564.6 g/mol
Molecular Formula C29H36N6O6
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count11
Rotatable Bond Count7
Exact Mass564.26963289 g/mol
Monoisotopic Mass564.26963289 g/mol
Topological Polar Surface Area207 Ų
Heavy Atom Count41
Formal Charge0
Complexity822
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. 1).

Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5. 1).


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Increased Megakaryocyte Maturation [PE]; Increased Platelet Production [PE]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Thrombopoietin Receptor Agonist [EPC]; Thrombopoietin Receptor Agonists [MoA]; UGT1A1 Inhibitors [MoA]; UGT1A3 Inhibitors [MoA]; UGT1A4 Inhibitors [MoA]; UGT1A6 Inhibitors [MoA]; UGT1A9 Inhibitors [MoA]; UGT2B15 Inhibitors [MoA]; UGT2B7 Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
5.2 ATC Code

B02BX05


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AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"KUALA LUMPUR - INT\\'L","customer":"NOVUGEN PHARMA SDN.BHD","customerCountry":"MALAYSIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"5000","totalValueFC":"4897.3","currency":"USD","unitRateINR":410399,"date":"14-Sep-2024","totalValueINR":"410399","totalValueInUsd":"4897.3","indian_port":"Hyderabad Air","hs_no":"29163110","bill_no":"4009519","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"ELTROMBOPAG OLAMINE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ALMATY","customer":"ABDI IBRAHIM","customerCountry":"KAZAKHSTAN","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"6500","totalValueFC":"38458.2","currency":"USD","unitRateINR":537140.66666666663,"date":"27-Sep-2024","totalValueINR":"3222844","totalValueInUsd":"38458.2","indian_port":"Hyderabad Air","hs_no":"29163110","bill_no":"4404985","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"KAZAKHSTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"ELTROMBOPAG OLAMINE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"ABDI IBRAHIM","customerCountry":"TURKEY","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"6750","totalValueFC":"26501.5","currency":"USD","unitRateINR":555214.5,"date":"28-Sep-2024","totalValueINR":"2220858","totalValueInUsd":"26501.5","indian_port":"Hyderabad Air","hs_no":"29163110","bill_no":"4421678","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678905000,"product":"ELTROMBOPAG OLAMINE MICRONIZED (BATCH NO.EPMA3302) (ELTROMBOPAG OLAMINE MICRONIZED)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"CHEMO","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.13","actualQuantity":"0.125","unit":"KGS","unitRateFc":"9200","totalValueFC":"1167.5","currency":"USD","unitRateINR":"768200","date":"16-Mar-2023","totalValueINR":"96025","totalValueInUsd":"1167.5","indian_port":"BOMBAY AIR","hs_no":"29147990","bill_no":"5072987","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683829800,"product":"ELTROMBOPAG OLAMINE MICRONIZED BATCH NO EPMA3303 ELTROMBOPAG OLAMINE MICRONIZED","address":"B,2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD","city":"MUMBAI","supplier":"CHEMO","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"9200","totalValueFC":"18470.6","currency":"USD","unitRateINR":"759920","date":"12-May-2023","totalValueINR":"1519840","totalValueInUsd":"18470.6","indian_port":"BOMBAY AIR","hs_no":"29147990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Spain","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"","customerAddress":"B,2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694629800,"product":"ELTROMBOPAG OLAMINE MICRONIZED (BATCH NO.EPMA3304) (ELTROMBOPAG OLAMINE MICRONIZED)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"CHEMO","supplierCountry":"SPAIN","foreign_port":"MADRID","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"9200","totalValueFC":"1860.9","currency":"USD","unitRateINR":"772340","date":"14-Sep-2023","totalValueINR":"154468","totalValueInUsd":"1860.9","indian_port":"Bombay Air","hs_no":"29147990","bill_no":"7828482","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"MADRID","supplierAddress":"MANUEL POMBO ANGULO, 28, 3RD FLOOR28050 MADRID SPAIN Madrid, , SpainSDNF Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701369000,"product":"ELTROMBOPAG OLAMINE","address":"SECOND FLOOR, BLOCK-III,MY HOME HUB","city":"HYDERABAD, AP","supplier":"UNIPHARM LTD","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"GRANULES INDIA LIMITED","customerCountry":"INDIA","quantity":"11.50","actualQuantity":"11.5","unit":"KGS","unitRateFc":"6100","totalValueFC":"70872.1","currency":"USD","unitRateINR":"513010","date":"01-Dec-2023","totalValueINR":"5899615","totalValueInUsd":"70872.1","indian_port":"Hyderabad Air","hs_no":"29141990","bill_no":"9027545","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"1, SHEVET SHIMON STREET REG NO.510457666 TEL AVIVSDNF Israel","customerAddress":"SECOND FLOOR, BLOCK-III,MY HOME HUB"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717785000,"product":"(FOC) ELTROMBOPAG OLAMINE API","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"ACTAVIS INC","supplierCountry":"INDIA","foreign_port":"MIAMI, FL","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"76.5","totalValueFC":"463.5","currency":"USD","unitRateINR":"7738.7","date":"08-Jun-2024","totalValueINR":"38693.7","totalValueInUsd":"463.5","indian_port":"Bombay Air","hs_no":"29331930","bill_no":"3907450","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MIAMI, FL","supplierAddress":"2945 WEST CORPORATE LAKES BLVD WESTON, FLORIDA 33331 ., , United States United States","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"}]
24-Apr-2021
28-Sep-2024
KGS
overview
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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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Europe

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Eltrombopag

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Eltrombopag

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Eltrombopag

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Eltrombopag

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q2 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

05

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

Eltrombopagum

Brand Name : Revolade

Dosage Form : Filmtable

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

Eltrombopagum

Brand Name : Revolade

Dosage Form : Filmtable

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

Eltrombopagum

Brand Name : Revolade

Dosage Form : Filmtable

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

08

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

Eltrombopagum

Brand Name : Revolade

Dosage Form : Filmtable

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

Eltrombopagum

Brand Name : Revolade

Dosage Form : Filmtabl

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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SupplySide West 2024
Not Confirmed
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SupplySide West 2024
Not Confirmed

Eltrombopagum

Brand Name : Revolade

Dosage Form : Filmtable

Dosage Strength : 12.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 12.5MG ACID

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 25MG ACID

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 50MG ACID

USFDA APPLICATION NUMBER - 22291

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DOSAGE - TABLET;ORAL - EQ 75MG ACID

USFDA APPLICATION NUMBER - 22291

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