Overview
A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase.
Indication
For the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea, and mild to moderate pain, inflammation, and fever.
Associated Conditions
- Mild pain
- Primary Dysmenorrhoea
- Gastrointestinal cramping
- Moderate Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/04/16 | Not Applicable | Recruiting | |||
2024/02/26 | Phase 1 | Completed | |||
2021/10/01 | Phase 1 | Completed | |||
2021/05/26 | Phase 1 | Completed | |||
2017/10/27 | Phase 2 | Completed | Hanan Nabil | ||
2017/03/03 | Phase 1 | Completed | |||
2016/10/25 | Phase 3 | Completed | |||
2015/04/15 | Phase 2 | Completed | |||
2014/07/08 | Phase 2 | Completed | |||
2013/09/13 | Phase 2 | Completed | Dexa Medica Group |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Micro Labs Limited | 42571-258 | ORAL | 250 mg in 1 1 | 1/12/2023 | |
Belcher Pharmaceuticals,LLC | 62250-677 | ORAL | 250 mg in 1 1 | 10/5/2023 | |
Advanced Rx Pharmacy of Tennessee, LLC | 80425-0306 | ORAL | 250 mg in 1 1 | 4/6/2023 | |
Misemer Pharmaceuticals, Inc | 0276-0509 | ORAL | 250 mg in 1 1 | 12/13/2022 | |
Lupin Pharmaceuticals, Inc. | 68180-185 | ORAL | 250 mg in 1 1 | 1/19/2024 |
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 |
---|---|---|---|---|---|
PONTALON FILM COATED TABLET 500 mg | SIN07726P | TABLET, FILM COATED | 500 mg | 5/19/1994 | |
FENAGESIC-500 TABLET 500 mg | SIN05718P | TABLET, FILM COATED | 500 mg | 4/8/1991 | |
BEAFEMIC CAPSULES 250 mg | SIN05376P | CAPSULE | 250 mg | 1/29/1991 | |
ORCIGESIC TABLETS | SIN06047P | TABLET, FILM COATED | 250 mg | 5/24/1991 | |
FENAGESIC SUSPENSION 125 mg/5 ml | SIN05488P | SUSPENSION | 125 mg/5 ml | 2/19/1991 | |
MEFRIL-250 CAPSULE 250 mg | SIN10125P | CAPSULE | 250 mg | 10/2/1998 | |
MEDICAP CAPSULE 250 mg | SIN05454P | CAPSULE | 250 mg | 2/19/1991 | |
FENAGESIC TABLETS 250 mg | SIN05717P | TABLET, FILM COATED | 250 mg | 4/8/1991 | |
PONTALON CAPSULE 250 mg | SIN08483P | CAPSULE | 250 mg | 12/16/1995 | |
FENAGESIC CAPSULES 250 mg | SIN05487P | CAPSULE | 250 mg | 2/19/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Mefenamic Acid Dspersible Tablets | 国药准字H20080405 | 化学药品 | 片剂 | 4/14/2023 | |
Mefenamic Acid Capsules | 国药准字H61020177 | 化学药品 | 胶囊剂 | 6/28/2021 | |
Mefenamic Acid Capsules | 国药准字H61021997 | 化学药品 | 胶囊剂 | 8/3/2020 | |
Mefenamic Acid Capsules | 国药准字H61020447 | 化学药品 | 胶囊剂 | 7/31/2020 | |
Mefenamic Acid Capsules | 国药准字H33022500 | 化学药品 | 胶囊剂 | 5/22/2020 | |
Mefenamic Acid Capsules | 国药准字H51022940 | 化学药品 | 胶囊剂 | 6/17/2020 | |
Mefenamic Acid Capsules | 国药准字H50021520 | 化学药品 | 胶囊剂 | 7/16/2020 | |
Mefenamic Acid Capsules | 国药准字H62020272 | 化学药品 | 胶囊剂 | 4/10/2020 | |
Mefenamic Acid Capsules | 国药准字H50020390 | 化学药品 | 胶囊剂 | 9/10/2020 | |
Mefenamic Acid Capsules | 国药准字H37020236 | 化学药品 | 胶囊剂 | 5/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
MEFENAMIC ACID CAP 250MG | N/A | N/A | N/A | 4/26/1979 | |
ELOKWEI MEFENAMIC ACID TABLETS 500MG | N/A | N/A | N/A | 11/11/2024 | |
SHUTON CAPSULES 250MG | N/A | N/A | N/A | 9/13/2024 | |
EFORMAT MEFENAMIC ACID TABLETS 500MG | N/A | N/A | N/A | 11/11/2024 | |
PRESITON TABLETS 250MG | N/A | N/A | N/A | 12/10/2019 | |
MEFENAM CAPSULES 250MG | N/A | N/A | N/A | 12/31/2015 | |
METSYN CAP 250MG | N/A | synco (h.k.) limited | N/A | N/A | 10/6/2016 |
TOEEFON TAB 250MG. | N/A | N/A | N/A | 3/15/2008 | |
SUITONE TABLETS 500MG | N/A | N/A | N/A | 11/11/2024 | |
PONSGESIC CAP 250MG | N/A | N/A | N/A | 10/18/1983 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
PONSTAN mefenamic acid 250mg capsule blister pack | 225658 | Medicine | A | 7/29/2014 | |
MENAMIC MLabs mefenamic acid 250 mg capsule bottle | 275275 | Medicine | A | 7/7/2017 | |
FEMIN mefenamic acid 250mg capsule bottle | 275277 | Medicine | A | 7/7/2017 | |
PONSTAN mefenamic acid 250mg capsule blister pack | 14388 | Medicine | A | 9/20/1991 | |
MENOPAIN mefenamic acid 250mg capsule bottle | 301376 | Medicine | A | 3/28/2018 | |
MEFENAMIC ACID MLabs mefenamic acid 250 mg capsule bottle | 275276 | Medicine | A | 7/7/2017 | |
MEFENAMIC ACID MLPL mefenamic acid 250mg capsule bottle | 275274 | Medicine | A | 7/7/2017 | |
FEMIN mefenamic acid 250 mg capsule bottle | 301375 | Medicine | A | 3/28/2018 |
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