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Also known as: 61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox
Molecular Formula
C16H25N3O8S
Molecular Weight
419.5  g/mol
InChI Key
MQXQVCLAUDMCEF-CWLIKTDRSA-N
FDA UNII
804826J2HU

Amoxicillin Trihydrate
A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.
1 2D Structure

Amoxicillin Trihydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid;trihydrate
2.1.2 InChI
InChI=1S/C16H19N3O5S.3H2O/c1-16(2)11(15(23)24)19-13(22)10(14(19)25-16)18-12(21)9(17)7-3-5-8(20)6-4-7;;;/h3-6,9-11,14,20H,17H2,1-2H3,(H,18,21)(H,23,24);3*1H2/t9-,10-,11+,14-;;;/m1.../s1
2.1.3 InChI Key
MQXQVCLAUDMCEF-CWLIKTDRSA-N
2.1.4 Canonical SMILES
CC1(C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O
2.1.5 Isomeric SMILES
CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O
2.2 Other Identifiers
2.2.1 UNII
804826J2HU
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Actimoxi

2. Amoxicillin

3. Amoxicillin Anhydrous

4. Amoxicillin Monopotassium Salt

5. Amoxicillin Monosodium Salt

6. Amoxicillin Sodium

7. Amoxicillin, (r*)-isomer

8. Amoxicilline

9. Amoxil

10. Amoxycillin

11. Brl 2333

12. Brl-2333

13. Brl2333

14. Clamoxyl

15. Clamoxyl G.a.

16. Clamoxyl Parenteral

17. Hydroxyampicillin

18. Penamox

19. Polymox

20. Trimox

21. Wymox

2.3.2 Depositor-Supplied Synonyms

1. 61336-70-7

2. Larotid

3. Polymox

4. Trimox

5. Utimox

6. Wymox

7. Clamoxyl

8. Amoxil

9. Amoxipen

10. Moxaline

11. Amodex

12. Zimox

13. Robamox

14. Dispermox

15. Novabritine

16. Hiconcil

17. Imacillin

18. Amoxycillin Trihydrate

19. Brl 2333

20. Moxatag

21. 61336-70-7 (hydrate)

22. Topramoxin

23. Amoxyke

24. Atoksilin

25. Demoksil

26. Largopen

27. Moksilin

28. Promoxil

29. Remoxil

30. Damoxy

31. 804826j2hu

32. (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

33. Amoksicillin

34. Kentrocyllin

35. Zamocilline

36. Alfamox

37. Amophar

38. Amoxidal

39. Amoxillat

40. Amoxina

41. Amoxine

42. Flemoxine

43. Galenamox

44. Gramidil

45. Himinomax

46. Izoltil

47. Matasedrin

48. Metifarma

49. Pacetocin

50. Pamocil

51. Paradroxil

52. Siganopen

53. Simplamox

54. Sintopen

55. Velamox

56. Zamocillin

57. Amoran

58. Ciblor

59. Amoxicillin Hydrate

60. Amoxi-wolff

61. Uro-clamoxyl

62. Brl-2333

63. Amoxi-diolan

64. Amox

65. Amoksicillin Forte

66. A-gram

67. Dura Ax

68. Amoxicillin [usan]

69. Amoxicillin-ratiopharm

70. Drg-0075

71. Amoxicillin (as Trihydrate)

72. (2s,5r,6r)-6-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

73. (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid;trihydrate

74. Amoxicillin Hydrate (1:3)

75. Neotetranase

76. Sawacillin

77. Pasetocin

78. Eupen

79. Amoxil Trihydrate

80. Unii-804826j2hu

81. Alpha-amino-p-hydroxybenzylpenicillin Trihydrate

82. Amoxipen Trihydrate

83. Dispermox (tn)

84. Moxaline Trihydrate

85. Pasetocin (tn)

86. (2s,5r,6r)-6-{[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

87. Amoxicillin (usp)

88. Amoxicillin Pulsys

89. Amoxicillin-trihydrat

90. Amoxicilline (inn)

91. Amoxil (tn)

92. Amoxicillin [usan:usp:inn:ban:jan]

93. (2s,5r,6r)-6-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

94. Amoxicillin [vandf]

95. Amoxicillin Hydrate (jp17)

96. Amoxicillin [usp-rs]

97. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid Trihydrate

98. Dtxsid2022599

99. Chebi:51254

100. Amoxicillin [orange Book]

101. Amoxicillin Hydrate [jan]

102. Apc-111

103. Amoxicillin [usp Impurity]

104. Amoxicillin [usp Monograph]

105. Amoxicillin Trihydrate [mi]

106. Prevpac Component Amoxicillin

107. Talicia Component Amoxicillin

108. Mfcd00072029

109. S5298

110. Amoxicillin Trihydrate [vandf]

111. Augmentin Component Amoxicillin

112. Akos015896673

113. Amoxicillin Trihydrate [mart.]

114. Amoxicillin Component Of Prevpac

115. Amoxicillin Component Of Talicia

116. Amoxicillin Trihydrate [who-dd]

117. Amoxicillin Trihydrate [who-ip]

118. Ccg-268878

119. Ks-5338

120. Amoxicillin Component Of Augmentin

121. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate (2s-(2alpha,5alpha,6beta(s*)))-

122. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2alpha,5alpha,6beta(s*)))-

123. Amoxicillin Trihydrate [green Book]

124. Amoxicillin Trihydrate [ep Monograph]

125. Clavulox Component Amoxicillin Trihydrate

126. D00229

127. Amoxicillinum Trihydricum [who-ip Latin]

128. A833170

129. Amoxicillin Trihydrate Component Of Clavulox

130. Q27122483

131. Amoxil Trihydrate;amoxipen Trihydrate;moxaline Trihydrate

132. Amoxicillin Trihydrate, Vetranal(tm), Analytical Standard

133. Amoxicillin, United States Pharmacopeia (usp) Reference Standard

134. Amoxicillin Trihydrate, British Pharmacopoeia (bp) Reference Standard

135. Amoxicillin Trihydrate, European Pharmacopoeia (ep) Reference Standard

136. Amoxicillin Trihydrate, Pharmaceutical Secondary Standard; Certified Reference Material

137. (2s,5r)-6-[[2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

138. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicycl(3.2.0)heptane-2-carboxylic Acid Trihydrate

139. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((2r)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate, (2s,5r,6r)-

140. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2.alpha.,5.alpha.,6.beta.(s*)))-

141. 6beta-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-2,2-dimethylpenam-3alpha-carboxylic Acid Trihydrate

142. Amoxicillin Trihydrate For Performance Verification, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 419.5 g/mol
Molecular Formula C16H25N3O8S
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count10
Rotatable Bond Count4
Exact Mass419.13623594 g/mol
Monoisotopic Mass419.13623594 g/mol
Topological Polar Surface Area161 Ų
Heavy Atom Count28
Formal Charge0
Complexity590
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameAmoxil
Active IngredientAmoxicillin
Dosage FormTablet; Capsule; Tablet, chewable; For suspension
RouteOral
Strength875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

2 of 6  
Drug NameLarotid
PubMed HealthAmoxicillin (By mouth)
Drug ClassesAntibiotic
Drug LabelMOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi...
Active IngredientAmoxicillin
Dosage FormFor suspension
RouteOral
Strength250mg/5ml; 125mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

3 of 6  
Drug NameMoxatag
Active IngredientAmoxicillin
Dosage FormTablet, extended release
RouteOral
Strength775mg
Market StatusPrescription
CompanyPragma Pharms

4 of 6  
Drug NameAmoxil
Active IngredientAmoxicillin
Dosage FormTablet; Capsule; Tablet, chewable; For suspension
RouteOral
Strength875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

5 of 6  
Drug NameLarotid
PubMed HealthAmoxicillin (By mouth)
Drug ClassesAntibiotic
Drug LabelMOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi...
Active IngredientAmoxicillin
Dosage FormFor suspension
RouteOral
Strength250mg/5ml; 125mg/5ml
Market StatusPrescription
CompanyDr Reddys Labs

6 of 6  
Drug NameMoxatag
Active IngredientAmoxicillin
Dosage FormTablet, extended release
RouteOral
Strength775mg
Market StatusPrescription
CompanyPragma Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


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01-Jan-2021
31-Aug-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna Triple Pack

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Phathom Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 24, 2022

Evonik company banner

01

Evonik

Germany
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Lead Product(s) : Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Phathom Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Agreement

Details : Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.

Brand Name : Voquezna Triple Pack

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 24, 2022

Evonik company banner

Details:

Talicia is a novel, fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection.


Lead Product(s): Amoxicillin Trihydrate,Rifabutin,Omeprazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 21, 2024

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02

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Talicia is a novel, fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection.

Brand Name : Talicia

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 21, 2024

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Details:

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.


Lead Product(s): Amoxicillin Trihydrate,Rifabutin,Omeprazole

Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 27, 2023

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03

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.

Brand Name : Talicia

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 27, 2023

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Details:

VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. It has been approved by FDA for the treatment of H. pylori infection in adults.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna Triple Pak

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 30, 2023

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04

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. It has been approved by FDA for the treatment of H. pylori infection in a...

Brand Name : Voquezna Triple Pak

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 30, 2023

blank

Details:

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.


Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 18, 2023

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05

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the U.S. FDA for the treatment of H. pylori infection in adults.

Brand Name : Talicia

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 18, 2023

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Details:

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics and a proton pump inhibitor (PPI) (omeprazole), used for the treatment of H. pylori infection.


Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 01, 2023

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06

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics and a proton pump inhibitor (PPI) (omeprazole), used for the treatment of H. pylori infection.

Brand Name : Talicia

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 01, 2023

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Details:

Under the agreement, RedHill will make Talicia, a novel, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole magnesium), approved for H. pylori infection, available via the PhilRx Patient Access Platform.


Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Phil

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 06, 2023

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07

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Under the agreement, RedHill will make Talicia, a novel, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole magnesium), approved for H. pylori infection, available via the PhilRx Pat...

Brand Name : Talicia

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 06, 2023

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Details:

Amoxicillin oral suspension is one of the most commonly prescribed antibiotics for children for the treatment of particular bacterial infections. Amoxicillin represents the first product that Juno will successfully import to address drug shortages through this division.


Lead Product(s): Amoxicillin Trihydrate

Therapeutic Area: Infections and Infectious Diseases Brand Name: Amoxicillin-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 04, 2023

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08

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Amoxicillin oral suspension is one of the most commonly prescribed antibiotics for children for the treatment of particular bacterial infections. Amoxicillin represents the first product that Juno will successfully import to address drug shortages throug...

Brand Name : Amoxicillin-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 04, 2023

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Details:

Voquezna (vonoprazan) new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Voquezna

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Phathom Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2022

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Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Voquezna (vonoprazan) new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years...

Brand Name : Voquezna

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 09, 2022

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Details:

Talicia (Omeprazole Magnesium) efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H. pylori eradication therapy.


Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Talicia

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 25, 2022

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10

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Talicia (Omeprazole Magnesium) efficacy and safety profile evaluated in patients with H. pylori infection and diabetes mellitus, a large and challenging patient population associated with sub-optimal outcomes with clarithromycin-based H. pylori eradicati...

Brand Name : Talicia

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 25, 2022

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INTERMEDIATES SUPPLIERS

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Discovery on Target
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Discovery on Target
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CAS Number : 69416-61-1

End Use API : Amoxicillin Trihydrate

About The Company : Zhejiang Apeloa Medical Technology Co., Ltd.(Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.) is a medicinal industry enterprise integrating R&D, manufacturing...

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02

Discovery on Target
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Discovery on Target
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CAS Number : 51997-51-4

End Use API : Amoxicillin Trihydrate

About The Company : Zhejiang Apeloa Medical Technology Co., Ltd.(Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd.) is a medicinal industry enterprise integrating R&D, manufacturing...

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50564

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DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50564

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DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

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DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50575

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DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

USFDA APPLICATION NUMBER - 50720

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DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

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DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

USFDA APPLICATION NUMBER - 50725

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DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50754

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DOSAGE - TABLET;ORAL - 875MG **Federal Regist...DOSAGE - TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50754

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DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

USFDA APPLICATION NUMBER - 50755

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DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50757

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DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Fe...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50760

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DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML

USFDA APPLICATION NUMBER - 50760

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE

USFDA APPLICATION NUMBER - 50785

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG

USFDA APPLICATION NUMBER - 50813

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DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50824

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