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DRUG PRODUCT COMPOSITIONS0
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| Molecular Weight | 136.11 g/mol |
|---|---|
| Molecular Formula | C5H4N4O |
| XLogP3 | -0.5 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 0 |
| Exact Mass | 136.03851076 g/mol |
| Monoisotopic Mass | 136.03851076 g/mol |
| Topological Polar Surface Area | 65.8 A^2 |
| Heavy Atom Count | 10 |
| Formal Charge | 0 |
| Complexity | 275 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 10 | |
|---|---|
| Drug Name | Allopurinol |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37C is 80 mg/dL and is greater in an alkaline solution. Allopurinol Table... |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Watson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan |
| 2 of 10 | |
|---|---|
| Drug Name | Allopurinol sodium |
| PubMed Health | Allopurinol (Injection) |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophi... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Eurohlth Intl |
| 3 of 10 | |
|---|---|
| Drug Name | Aloprim |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ZYLOPRIM (allopurinol) has the following structural formula:ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allo... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Mylan Institutional |
| 4 of 10 | |
|---|---|
| Drug Name | Lopurin |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Dr Reddys La |
| 5 of 10 | |
|---|---|
| Drug Name | Zyloprim |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Prometheus Labs |
| 6 of 10 | |
|---|---|
| Drug Name | Allopurinol |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | Allopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37C is 80 mg/dL and is greater in an alkaline solution. Allopurinol Table... |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Watson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan |
| 7 of 10 | |
|---|---|
| Drug Name | Allopurinol sodium |
| PubMed Health | Allopurinol (Injection) |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophi... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Eurohlth Intl |
| 8 of 10 | |
|---|---|
| Drug Name | Aloprim |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ZYLOPRIM (allopurinol) has the following structural formula:ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allo... |
| Active Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Mylan Institutional |
| 9 of 10 | |
|---|---|
| Drug Name | Lopurin |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Dr Reddys La |
| 10 of 10 | |
|---|---|
| Drug Name | Zyloprim |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Prometheus Labs |
API SUPPLIERS
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37104
Submission : 2023-01-20
Status : Active
Type : II
Certificate Number : CEP 2023-029 - Rev 00
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 576
Status : Valid
NDC Package Code : 49716-328
Start Marketing Date : 2023-10-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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DMF Number : 39568
Submission : 2024-03-05
Status : Active
Type : II
NDC Package Code : 61281-9750
Start Marketing Date : 2023-07-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : CEP 2014-364 - Rev 01
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Status : Valid
Registration Number : 231MF10077
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2019-03-29
Latest Date of Registration : --
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-01-25
Registration Number : 20210125-209-J-511
Manufacturer Name : EGIS Pharmaceuticals Plc.
Manufacturer Address : Kereszturi ut 30-38., Budapest, 1106, Hungary
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24876
Submission : 2011-04-15
Status : Active
Type : II
Certificate Number : R1-CEP 2002-164 - Rev 00
Issue Date : 2009-01-13
Type : Chemical
Substance Number : 576
Status : Valid
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Certificate Number : CEP 2023-029 - Rev 00
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 576
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Allopurinol, Synthetic route B
Certificate Number : CEP 2014-364 - Rev 01
Status : Valid
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : R1-CEP 1996-032 - Rev 05
Status : Valid
Issue Date : 2019-08-09
Type : Chemical
Substance Number : 576
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : R1-CEP 2002-164 - Rev 00
Status : Valid
Issue Date : 2009-01-13
Type : Chemical
Substance Number : 576
TAPI offers customized CDMO Solutions for API development and manufacturing services.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Allopurinol, Allopurinol P-process
Certificate Number : CEP 2014-117 - Rev 02
Status : Valid
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 576
TAPI offers customized CDMO Solutions for API development and manufacturing services.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Certificate Number : R1-CEP 1999-007 - Rev 07
Status : Valid
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2007-189 - Rev 00
Status : Expired
Issue Date : 2010-06-30
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2003-213 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2004-189 - Rev 02
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2008-09-26
Type : Chemical
Substance Number : 576
Certificate Number : R1-CEP 2003-004 - Rev 02
Status : Valid
Issue Date : 2017-12-15
Type : Chemical
Substance Number : 576
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 100mg
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
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Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 300mg
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Approval Date :
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Registration Country : Switzerland
Aspen API. More than just an API.
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Brand Name : Zyloric
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Dosage Strength : 100 MG
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Registration Country : Sweden
Aspen API. More than just an API.
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Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : TABLET
Dosage Strength : 300 MG
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Registration Country : Sweden
Aspen API. More than just an API.
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Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Blister
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Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Box
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Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
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Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 300 mg
Packaging : Blister
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Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API.
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Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 300 mg
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Packaging : 200
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Brand Name : Progout 300
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Brand Name : Allopurinol APOTEX
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 200
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Allopurinol APOTEX
Dosage Form : tablet
Dosage Strength : 300 mg
Packaging : 60
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Allopurinol APOTEX
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 200
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Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Allopurinol APOTEX
Dosage Form : tablet
Dosage Strength : 300 mg
Packaging : 60
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Regulatory Info :
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Brand Name : Allosig
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Packaging : 200
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Regulatory Info :
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Brand Name : Allosig
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Dosage Strength : 100 mg
Packaging : 200
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Brand Name : NOUMED ALLOPURINOL
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 200
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : NOUMED ALLOPURINOL
Dosage Form : tablet
Dosage Strength : 100 mg
Packaging : 200
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Puricos
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 100X1mg
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Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Puricos
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 500X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Puricos
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Puricos
Dosage Form : TAB
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Packaging : 250X1mg
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Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zyloprim
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 150X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zyloprim
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Zyloprim
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zyloprim 300
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Lonol Pt
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Lonol Pt
Dosage Form : TAB
Dosage Strength : 300mg
Packaging : 100X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 300MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG;200MG
USFDA APPLICATION NUMBER - 209203
DOSAGE - TABLET;ORAL - 300MG;200MG
USFDA APPLICATION NUMBER - 209203
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