Overview
Diflunisal, a salicylate derivative, is a nonsteroidal anti-inflammatory agent (NSAIA) with pharmacologic actions similar to other prototypical NSAIAs. Diflunisal possesses anti-inflammatory, analgesic and antipyretic activity. Though its mechanism of action has not been clearly established, most of its actions appear to be associated with inhibition of prostaglandin synthesis via the arachidonic acid pathway. Diflunisal is used to relieve pain accompanied with inflammation and in the symptomatic treatment of rheumatoid arthritis and osteoarthritis.
Indication
For symptomatic treatment of mild to moderate pain accompanied by inflammation (e.g. musculoskeletal trauma, post-dental extraction, post-episiotomy), osteoarthritis, and rheumatoid arthritis.
Associated Conditions
- Mild pain
- Osteoarthritis (OA)
- Rheumatoid Arthritis
- Moderate Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/10/03 | Phase 1 | Completed | |||
2012/08/30 | Phase 4 | Terminated | |||
2011/09/13 | N/A | Completed | |||
2006/02/22 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| H. J. Harkins Company Inc. | 52959-379 | ORAL | 500 mg in 1 1 | 12/21/2017 | |
| Chartwell RX, LLC | 62135-456 | ORAL | 500 mg in 1 1 | 2/1/2023 | |
| Zydus Lifesciences Limited | 70771-1083 | ORAL | 500 mg in 1 1 | 11/16/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0093-9222 | ORAL | 500 mg in 1 1 | 10/29/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DIFLUNISAL | aa pharma inc | 02039486 | Tablet - Oral | 250 MG | 12/31/1993 |
| NU-DIFLUNISAL TAB 250MG | nu-pharm inc | 02058405 | Tablet - Oral | 250 MG | 12/31/1994 |
| NOVO-DIFLUNISAL | teva canada limited | 02048493 | Tablet - Oral | 250 MG | 12/31/1993 |
| NOVO-DIFLUNISAL | teva canada limited | 02048507 | Tablet - Oral | 500 MG | 12/31/1993 |
| DOLOBID TAB 250MG | merck frosst canada & cie, merck frosst canada & co. | 00587699 | Tablet - Oral | 250 MG / TAB | 12/31/1983 |
| DOLOBID TAB 500MG | merck frosst canada & cie, merck frosst canada & co. | 00576131 | Tablet - Oral | 500 MG / TAB | 12/31/1983 |
| NU-DIFLUNISAL TAB 500MG | nu-pharm inc | 02058413 | Tablet - Oral | 500 MG | 12/31/1994 |
| DIFLUNISAL-500 - TAB 500MG | PRO DOC LIMITEE | 02130912 | Tablet - Oral | 500 MG / TAB | 12/31/1995 |
| DIFLUNISAL-250 - TAB 250MG | PRO DOC LIMITEE | 02130904 | Tablet - Oral | 250 MG / TAB | 12/31/1995 |
| DIFLUNISAL | aa pharma inc | 02039494 | Tablet - Oral | 500 MG | 12/31/1993 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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