Overview
A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.
Indication
For treatment of osteoarthritis and rheumatoid arthritis.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Osteoarthritis (OA)
- Rheumatoid Arthritis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/08/03 | Phase 2 | Completed | Dr. Hang Wun Raymond Li | ||
2018/08/02 | Early Phase 1 | UNKNOWN | |||
2015/05/21 | Phase 4 | Completed | |||
2014/12/02 | Phase 3 | Completed | |||
2014/10/01 | Phase 4 | Completed | |||
2011/03/22 | Phase 2 | Completed | |||
2008/05/01 | Phase 2 | Completed | |||
2008/04/01 | Phase 4 | Completed | |||
2008/03/07 | Phase 4 | Completed | University Hospital of Split |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 71335-2067 | ORAL | 20 mg in 1 1 | 5/26/2021 | |
| Bryant Ranch Prepack | 63629-9149 | ORAL | 20 mg in 1 1 | 2/19/2020 | |
| Greenstone LLC | 59762-0145 | ORAL | 20 mg in 1 1 | 2/2/2023 | |
| AvKARE | 42291-674 | ORAL | 10 mg in 1 1 | 1/10/2024 | |
| Teva Pharmaceuticals USA, Inc. | 0093-0757 | ORAL | 20 mg in 1 1 | 2/14/2023 | |
| Bryant Ranch Prepack | 72162-1290 | ORAL | 10 mg in 1 1 | 2/19/2020 | |
| Bryant Ranch Prepack | 71335-1999 | ORAL | 20 mg in 1 1 | 2/10/2022 | |
| Bryant Ranch Prepack | 63629-9150 | ORAL | 20 mg in 1 1 | 2/19/2020 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-3230 | ORAL | 20 mg in 1 1 | 11/16/2022 | |
| Vensun Pharmaceuticals, Inc. | 42543-115 | ORAL | 20 mg in 1 1 | 3/2/2018 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Piroxicam Capsules | 国药准字H50020465 | 化学药品 | 胶囊剂 | 4/8/2020 | |
| Piroxicam Capsules | 国药准字H44022291 | 化学药品 | 胶囊剂 | 9/28/2020 | |
| Piroxicam Capsules | 国药准字H50020464 | 化学药品 | 胶囊剂 | 4/17/2020 | |
| Piroxicam Capsules | 国药准字H44021588 | 化学药品 | 胶囊剂 | 1/17/2020 | |
| Piroxicam Capsules | 国药准字H62020596 | 化学药品 | 胶囊剂 | 7/17/2020 | |
| Piroxicam Capsules | 国药准字H46020750 | 化学药品 | 胶囊剂 | 4/12/2022 | |
| Piroxicam Capsules | 国药准字H20003067 | 化学药品 | 胶囊剂 | 8/13/2020 | |
| Piroxicam Capsules | 国药准字H44020038 | 化学药品 | 胶囊剂 | 4/7/2020 | |
| Piroxicam Capsules | 国药准字H14020313 | 化学药品 | 胶囊剂 | 8/13/2020 | |
| Piroxicam Injection | 国药准字H20044975 | 化学药品 | 注射剂 | 9/13/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MOBILIS 20 piroxicam 20mg capsule bottle | 52202 | Medicine | A | 5/2/1995 | |
| GENRX PIROXICAM DISPERSIBLE piroxicam 10mg tablet blister pack | 78363 | Medicine | A | 7/3/2001 | |
| MOBILIS D-20 piroxicam 20mg dispersible tablet blister pack | 53284 | Medicine | A | 8/8/1995 |
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