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Synopsis
DRUG PRODUCT COMPOSITIONS0
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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
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
| Molecular Weight | 419.5 g/mol |
|---|---|
| Molecular Formula | C16H25N3O8S |
| Hydrogen Bond Donor Count | 7 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 4 |
| Exact Mass | 419.13623594 g/mol |
| Monoisotopic Mass | 419.13623594 g/mol |
| Topological Polar Surface Area | 161 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 590 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 4 |
| 1 of 6 | |
|---|---|
| Drug Name | Amoxil |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet; Capsule; Tablet, chewable; For suspension |
| Route | Oral |
| Strength | 875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 2 of 6 | |
|---|---|
| Drug Name | Larotid |
| PubMed Health | Amoxicillin (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | MOXATAG (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 Ingredient | Amoxicillin |
| Dosage Form | For suspension |
| Route | Oral |
| Strength | 250mg/5ml; 125mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 3 of 6 | |
|---|---|
| Drug Name | Moxatag |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 775mg |
| Market Status | Prescription |
| Company | Pragma Pharms |
| 4 of 6 | |
|---|---|
| Drug Name | Amoxil |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet; Capsule; Tablet, chewable; For suspension |
| Route | Oral |
| Strength | 875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 5 of 6 | |
|---|---|
| Drug Name | Larotid |
| PubMed Health | Amoxicillin (By mouth) |
| Drug Classes | Antibiotic |
| Drug Label | MOXATAG (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 Ingredient | Amoxicillin |
| Dosage Form | For suspension |
| Route | Oral |
| Strength | 250mg/5ml; 125mg/5ml |
| Market Status | Prescription |
| Company | Dr Reddys Labs |
| 6 of 6 | |
|---|---|
| Drug Name | Moxatag |
| Active Ingredient | Amoxicillin |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | 775mg |
| Market Status | Prescription |
| Company | Pragma Pharms |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32811
Submission : 2018-05-15
Status : Active
Type : II
Certificate Number : CEP 2019-244 - Rev 02
Issue Date : 2023-12-18
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 55657-101
Start Marketing Date : 2005-08-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-30-A-341-24
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-14
Pay. Date : 2022-03-04
DMF Number : 36579
Submission : 2021-12-23
Status : Active
Type : II
Certificate Number : CEP 2021-461 - Rev 02
Issue Date : 2025-03-21
Type : Chemical
Substance Number : 260
Status : Valid
NDC Package Code : 55657-106
Start Marketing Date : 2005-08-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2019-11-21
Registration Number : 20191121-30-A-353-23
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-16
Pay. Date : 2022-03-07
DMF Number : 36698
Submission : 2022-02-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13525
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13552
Submission : 1998-09-01
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13498
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13207
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13201
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13481
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8845
Submission : 1990-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13215
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12895
Submission : 1998-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12904
Submission : 1998-03-18
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11483
Submission : 1995-04-28
Status : Inactive
Type : II
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11481
Submission : 1995-04-28
Status : Inactive
Type : II
Portfolio PDF
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Certificate Number : R1-CEP 2001-123 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2015-02-16
Type : Chemical
Substance Number : 260
Certificate Number : R1-CEP 2004-147 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-04-22
Type : Chemical
Substance Number : 260
Amoxicillin Trihydrate, Powder, Compacted And Mi...
Certificate Number : R0-CEP 1997-129 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2005-01-24
Type : Chemical
Substance Number : 260
Certificate Number : R1-CEP 2004-074 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-04-30
Type : Chemical
Substance Number : 260
Certificate Number : R1-CEP 1996-060 - Rev 03
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-12-20
Type : Chemical
Substance Number : 260
Certificate Number : R1-CEP 2004-266 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2012-11-16
Type : Chemical
Substance Number : 260
Amoxicillin Trihydrate, Mexico, Powder Material,...
Certificate Number : R2-CEP 1995-030 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2014-06-02
Type : Chemical
Substance Number : 260
Amoxicillin Trihydrate, For Veterinary Purposes ...
Certificate Number : R0-CEP 2007-018 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2013-05-28
Type : Chemical
Substance Number : 260
Certificate Number : R2-CEP 1994-013 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2009-07-03
Type : Chemical
Substance Number : 260
Amoxicillin Trihydrate, India, Process 1
Certificate Number : R1-CEP 2001-351 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2008-01-23
Type : Chemical
Substance Number : 260
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Hard Capsule
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 750MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Dispersible Tablet
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 125MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 250MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Regulatory Info :
Registration Country : Netherlands
Brand Name :
Dosage Form : Powder for Oral Suspension
Dosage Strength : 500MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Netherlands
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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 is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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 is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : AMOXICILLIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 1988-02-25
Application Number : 62881
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : AMOXICILLIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : 250MG
Approval Date : 1988-02-25
Application Number : 62884
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date : 2007-11-09
Application Number : 65373
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code :
Brand Name : UTIMOX
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 125MG/5ML
Approval Date : 1982-01-01
Application Number : 62127
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
Brand Name : TALICIA
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 250MG;EQ 10MG BASE;12.5MG
Approval Date : 2019-11-01
Application Number : 213004
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 500MG;EQ 125MG BASE
Approval Date : 2002-11-27
Application Number : 65117
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 400MG/5ML;EQ 57MG BASE/5ML
Approval Date : 2003-03-19
Application Number : 65132
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code : AB
AMOXICILLIN; CLAVULANATE POTASSIUM
Brand Name : AUGMENTIN 250
Dosage Form : FOR SUSPENSION;ORAL
Dosage Strength : 250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date : 1984-08-06
Application Number : 50575
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
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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
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
DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50575
DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE
USFDA APPLICATION NUMBER - 50720
DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
USFDA APPLICATION NUMBER - 50725
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
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
DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
USFDA APPLICATION NUMBER - 50755
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
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
DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML
USFDA APPLICATION NUMBER - 50760
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50785
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG
USFDA APPLICATION NUMBER - 50813
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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ABOUT THIS PAGE
47
PharmaCompass offers a list of Amoxicillin Trihydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier.
PharmaCompass also assists you with knowing the Amoxicillin Trihydrate API Price utilized in the formulation of products. Amoxicillin Trihydrate API Price is not always fixed or binding as the Amoxicillin Trihydrate Price is obtained through a variety of data sources. The Amoxicillin Trihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amoxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoxine, including repackagers and relabelers. The FDA regulates Amoxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoxine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Amoxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amoxine supplier is an individual or a company that provides Amoxine active pharmaceutical ingredient (API) or Amoxine finished formulations upon request. The Amoxine suppliers may include Amoxine API manufacturers, exporters, distributors and traders.
click here to find a list of Amoxine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amoxine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxine active pharmaceutical ingredient (API) in detail. Different forms of Amoxine DMFs exist exist since differing nations have different regulations, such as Amoxine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amoxine DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxine USDMF includes data on Amoxine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amoxine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Amoxine Drug Master File in Japan (Amoxine JDMF) empowers Amoxine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Amoxine JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Amoxine suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Amoxine Drug Master File in Korea (Amoxine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoxine. The MFDS reviews the Amoxine KDMF as part of the drug registration process and uses the information provided in the Amoxine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amoxine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Amoxine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Amoxine suppliers with KDMF on PharmaCompass.
A Amoxine CEP of the European Pharmacopoeia monograph is often referred to as a Amoxine Certificate of Suitability (COS). The purpose of a Amoxine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxine to their clients by showing that a Amoxine CEP has been issued for it. The manufacturer submits a Amoxine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxine CEP holder for the record. Additionally, the data presented in the Amoxine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxine DMF.
A Amoxine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Amoxine suppliers with CEP (COS) on PharmaCompass.
A Amoxine written confirmation (Amoxine WC) is an official document issued by a regulatory agency to a Amoxine manufacturer, verifying that the manufacturing facility of a Amoxine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxine APIs or Amoxine finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxine WC (written confirmation) as part of the regulatory process.
click here to find a list of Amoxine suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Amoxine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amoxine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Amoxine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Amoxine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amoxine suppliers with NDC on PharmaCompass.
Amoxine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Amoxine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Amoxine GMP manufacturer or Amoxine GMP API supplier for your needs.
A Amoxine CoA (Certificate of Analysis) is a formal document that attests to Amoxine's compliance with Amoxine specifications and serves as a tool for batch-level quality control.
Amoxine CoA mostly includes findings from lab analyses of a specific batch. For each Amoxine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Amoxine may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxine EP), Amoxine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxine USP).
