Overview
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties. Its therapeutic effects are due to its ability to inhibit prostaglandin synthesis. It is indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.
Indication
For acute and long-term management of signs and symptoms of osteoarthritis and rheumatoid arthritis, as well as for the management of pain.
Associated Conditions
- Acute Pain
- Chronic Back Pain
- Extra-Articular Rheumatism
- Juvenile Idiopathic Arthritis (JIA)
- Muscle Spasms
- Nonspecific Pain Post Traumatic Injury
- Osteoarthritis (OA)
- Postoperative pain
- Rheumatoid Arthritis
- Spinal Disorders
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/24 | Not Applicable | Recruiting | |||
2022/03/02 | Not Applicable | Completed | Yuzuncu Yıl University | ||
2017/04/25 | Phase 3 | Terminated | Apsen Farmaceutica S.A. | ||
2016/08/29 | Phase 4 | Completed | Flavia Pardo Salata Nahsan | ||
2013/04/15 | Phase 1 | Completed | |||
2013/04/10 | Phase 1 | Completed | |||
2012/12/13 | Phase 1 | Completed | |||
2012/12/11 | Phase 1 | Completed | |||
2012/11/28 | Phase 1 | Completed | |||
2012/11/28 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0093-1122 | ORAL | 400 mg in 1 1 | 4/29/2022 | |
| Preferred Pharmaceuticals Inc. | 68788-8846 | ORAL | 400 mg in 1 1 | 3/24/2025 | |
| Teva Pharmaceuticals USA, Inc. | 0093-1118 | ORAL | 600 mg in 1 1 | 4/29/2022 | |
| Edenbridge Pharmaceuticals LLC. | 42799-111 | ORAL | 400 mg in 1 1 | 12/10/2021 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0190 | ORAL | 400 mg in 1 1 | 12/21/2022 | |
| Edenbridge Pharmaceuticals LLC. | 42799-112 | ORAL | 500 mg in 1 1 | 12/10/2021 | |
| STAT Rx USA LLC | 42549-511 | ORAL | 400 mg in 1 1 | 4/3/2012 | |
| Bryant Ranch Prepack | 63629-8598 | ORAL | 600 mg in 1 1 | 10/4/2022 | |
| A-S Medication Solutions | 50090-2133 | ORAL | 500 mg in 1 1 | 11/3/2022 | |
| H.J. Harkins Company, Inc. | 52959-471 | ORAL | 400 mg in 1 1 | 8/30/2012 |
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 |
|---|---|---|---|---|---|
| Etodolac Sustained-release Tablets | 国药准字H20030552 | 化学药品 | 片剂(缓释) | 8/13/2020 | |
| Etodolac Sustained-release Tablets | 国药准字H20040507 | 化学药品 | 片剂 | 6/25/2021 | |
| Etodolac Capsules | 国药准字H20051816 | 化学药品 | 胶囊剂 | 2/6/2020 | |
| Etodolac Capsules | 国药准字H20041433 | 化学药品 | 胶囊剂 | 6/14/2020 | |
| Etodolac Tablets | 国药准字H20040831 | 化学药品 | 片剂 | 5/22/2020 | |
| Etodolac Tablets | 国药准字H20000479 | 化学药品 | 片剂 | 1/7/2020 | |
| Etodolac Tablets | 国药准字H20030458 | 化学药品 | 片剂 | 5/22/2020 |
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. | |||||
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