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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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About the Company : Established in 1869, Centrient Pharmaceuticals is a global B2B leader in sustainable, enzymatic antibiotics, next-generation statins and anti-fungals. Together with tablets, capsul...

Established in 1869, Centrient Pharmaceuticals is a global B2B leader in sustainable, enzymatic antibiotics, next-generation statins and anti-fungals. Together with tablets, capsules and finished dosage forms, it manufactures and markets intermediates and active pharmaceutical ingredients (APIs). It is a pharmaceutical company with a clear purpose — to improve lives through innovative and sustainable manufacturing of medicines. Centrient is committed to ensuring quality, reliability and sustainability for its customers, partners and patients. Its vision is to be the leading, diversified and fully integrated partner for generics marketers.
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Amoxicillin Trihydrate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Amoxicillin Trihydrate

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...

Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
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Amoxicillin

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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Amoxicillin Trihydrate

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

06

Bioquim

Spain
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euroPLX 86 Munich
Not Confirmed
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  • EDQM
  • WHO-GMP

Virtual BoothBioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

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Amoxicillin Trihydrate

About the Company : Bioquim is a European company specializing in bulk oral & sterile APIs for the pharmaceutical industry. With over 40 years of experience, we offer high-quality corticosteroids, pep...

Bioquim is a European company specializing in bulk oral & sterile APIs for the pharmaceutical industry. With over 40 years of experience, we offer high-quality corticosteroids, peptides, amino acids, penicillin derivatives, non-penicillin antibiotics, and HPAPIs for human & veterinary markets. We adhere to stringent GMP and operate state-of-the-art facilities with advanced technology. Bioquim also provides Custom Synthesis & Contract Manufacturing services, delivering tailored solutions backed by our expertise in chemical synthesis & lyophilization of sterile APIs. Trust Bioquim for your API needs & experience our commitment to quality.
Bioquim

07

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

Amoxicillin Trihydrate

About the Company : We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formula...

We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formulations (Solid and Injectable). We export our products to MORE than 100 countries all over the world. Our production sites, most of them regularly inspected by EUROPEN AND USA AUTHORITIES (FDA), have strict Quality Standards and our R&D Know-how make us a leading company. Our Commitment: to work in the present while concentrating on the future, because on markets where research and technology are factors of primary importance.
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08

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
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Amoxycillin

About the Company : Hebei Veyong Pharmaceutical Co., Ltd, was established in 2002 and located in Economic and Technological Development Zone in Shijiazhuang. It is a large veterinary enterprise with G...

Hebei Veyong Pharmaceutical Co., Ltd, was established in 2002 and located in Economic and Technological Development Zone in Shijiazhuang. It is a large veterinary enterprise with GMP certificate in China with research and development, production and sales of veterinary API and preparations. It is national high-tech enterprise, Hebei famous trademark enterprise, the vice-chairman company of Hebei Association of Animal Science and Veterinary Medicine, the vice-chairman company of Hebei Animal Health Products Association.
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09

euroPLX 86 Munich
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euroPLX 86 Munich
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Amoxicillin Trihydrate

About the Company : JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao I...

JIN DUN Medical Research Institute is affiliated to Shanghai JIN DUN Industrial Co., Ltd., headquartered in Shanghai, adjacent to Hongqiao High-speed Railway Station and Hongqiao International airport. JIN DUN Medical Research Institute is committed to providing pharmaceutical intermediates and raw materials with the purpose of innovative drug research. Customized R&D and customized production services.
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10

Sandoz B2B

Switzerland
euroPLX 86 Munich
Not Confirmed
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Sandoz B2B

Switzerland
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euroPLX 86 Munich
Not Confirmed

Amoxicillin Trihydrate

About the Company : Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners w...

Sandoz B2B provides access to an extensive portfolio of high-quality products and services, covering more than 20 therapeutic areas. Delivering unique added value to our partners with complete operational and technical support, we are dedicated to giving our customers the service that boosts their business.
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LTD.","customerCountry":"INDIA","quantity":"4390.00","actualQuantity":"4390","unit":"KGS","unitRateFc":"32.5","totalValueFC":"144327.4","currency":"USD","unitRateINR":"2757.6","date":"23-Aug-2024","totalValueINR":"12105973.75","totalValueInUsd":"144327.4","indian_port":"JNPT","hs_no":"29411030","bill_no":"5197514","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"INDUSTRY ZONE ,TUOKETUO, HOHHOT, INNER MONGOLIA CHINA Hohhot, , ChinaSDNF China","customerAddress":"A-5, MEGH MALHAR, GAVAND PATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729621800,"product":"AMOXICILLIN TRIHYDRATE COMPACTED CEP ( AMOXICILLIN TRIHYDRATE )","address":"A-5, MEGH MALHAR, GAVAND PATH,","city":"THANE ,MAHARASHTRA","supplier":"CSPC ZHONGRUN PHARMACEUTICAL INNER MONGOLIA","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"MILAN LABORATORIES INDIA PVT. LTD.","customerCountry":"INDIA","quantity":"4359.00","actualQuantity":"4359","unit":"KGS","unitRateFc":"31.5","totalValueFC":"138817.5","currency":"USD","unitRateINR":"2675.9","date":"23-Oct-2024","totalValueINR":"11664357.08","totalValueInUsd":"138817.5","indian_port":"JNPT","hs_no":"29411030","bill_no":"6284733","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"INDUSTRY ZONE ,TUOKETUO, HOHHOT, IN NER MONGOLIA CHINA Hohhot, , China SDNF China","customerAddress":"A-5, MEGH MALHAR, GAVAND PATH,"}]
01-Jan-2021
28-Oct-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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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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

blank

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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

American Pharma Summit
Not Confirmed
American Pharma Summit
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

blank

09

American Pharma Summit
Not Confirmed
American Pharma Summit
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

blank

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

blank

10

American Pharma Summit
Not Confirmed
American Pharma Summit
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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01

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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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

euroPLX 86 Munich
Not Confirmed
arrow
euroPLX 86 Munich
Not Confirmed
arrow

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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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Dispersible Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Dispersible Tablet

Dosage Strength : 750MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Dispersible Tablet

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Powder for Oral Suspension

Dosage Strength : 125MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Powder for Oral Suspension

Dosage Strength : 250MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Flag Netherlands
Digital Content Digital Content

Regulatory Info :

Registration Country : Netherlands

Amoxicillin Trihydrate

Brand Name :

Dosage Form : Powder for Oral Suspension

Dosage Strength : 500MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Netherlands

Centrient Pharmaceuticals

08

Sanofi

France
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American Pharma Summit
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Amoxicillinum anhydrous; Acidum clavulanicum

Brand Name : Co-Amoxicillin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

09

Sanofi

France
arrow
American Pharma Summit
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Amoxicillinum anhydrous; Acidum clavulanicum

Brand Name : Co-Amoxicillin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

10

Sanofi

France
arrow
American Pharma Summit
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Amoxicillinum anhydrous; Acidum clavulanicum

Brand Name : Co-Amoxicillin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 625mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner
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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

read-more

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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Coating Systems & Additives

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SPI Pharma

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ANALYTICAL

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Analytical Methods

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01

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YMC

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J'sphere ODS-H80

Product Code : JH08S04-L546WT

Classification : Antibiotics

Product Characteristics : O950920C

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YMC-Pack Pro C18

Product Code : AS12S03-0202CM

Classification : Antibiotics

Product Characteristics : A020620A

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Hydrosphere C18

Product Code : HS12S05-1546WT

Classification : Antibiotics

Product Characteristics : S000622D

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