Overview
A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.
Background
A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.
Indication
用于治疗帕金森病和吩噻嗪类药物引起的锥体外系症状，但对迟发性运动障碍无效。用于治疗急性肌骨骼疼痛
Associated Conditions
- Back Pain Lower Back
- Fever
- Menstrual Distress (Dysmenorrhea)
- Mild pain
- Muscle Spasms
- Mild Musculoskeletal Disorder
- Mild to moderate pain
- Moderate Musculoskeletal Disorder
- Moderate Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/10 | Phase 4 | Completed | |||
2020/08/12 | Not Applicable | Terminated | |||
2016/11/08 | Phase 4 | UNKNOWN | University of Illinois College of Medicine at Peoria | ||
2016/01/27 | Phase 4 | Completed | |||
2015/05/20 | Phase 4 | Completed | |||
2015/04/22 | Phase 3 | Recruiting | Sherief Abd-Elsalam | ||
2010/12/21 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 0591-3222 | INTRAMUSCULAR, INTRAVENOUS | 30 mg in 1 mL | 11/29/2018 | |
| St. Mary's Medical Park Pharmacy | 60760-810 | ORAL | 100 mg in 1 1 | 11/17/2023 | |
| Direct_Rx | 61919-177 | ORAL | 100 mg in 1 1 | 1/9/2024 | |
| Preferred Pharmaceuticals, Inc | 68788-9150 | ORAL | 100 mg in 1 1 | 11/20/2009 | |
| Physicians Total Care, Inc. | 54868-4102 | ORAL | 100 mg in 1 1 | 5/12/2011 | |
| Proficient Rx LP | 63187-632 | ORAL | 100 mg in 1 1 | 11/1/2019 | |
| Aidarex Pharmaceuticals LLC | 33261-088 | ORAL | 100 mg in 1 1 | 10/4/2012 | |
| STAT Rx USA LLC | 42549-559 | ORAL | 100 mg in 1 1 | 5/1/2012 | |
| Akorn | 17478-538 | INTRAMUSCULAR, INTRAVENOUS | 30 mg in 1 mL | 1/29/2024 | |
| Atland Pharmaceuticals, LLC | 71993-307 | ORAL | 50 mg in 1 1 | 6/19/2023 |
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 |
|---|---|---|---|---|---|
| CAMGESIC TABLET | SIN09867P | TABLET | 35 mg | 7/2/1998 | |
| SUNITON TABLETS | SIN05937P | TABLET | 35 mg | 5/21/1991 | |
| ANAREX TABLETS | SIN05584P | TABLET | 35 mg | 3/30/1991 | |
| ONADRINE TABLET 50 mg | SIN07611P | TABLET | 50 mg | 1/18/1994 | |
| ORPHENADOL TABLET | SIN07951P | TABLET | 50 mg | 12/9/1994 | |
| HORGESIC TABLET 35MG/450MG | SIN16415P | TABLET | 35 mg | 1/7/2022 | |
| NORPHEN TABLET | ATLANTIC LABORATORIES CORPN LTD | SIN12142P | TABLET | 35 mg | 12/5/2002 |
| ORCIGESIC CAPSULE | SIN07108P | CAPSULE | 35 mg | 7/10/1992 | |
| NORGESIC TABLET | SIN05552P | TABLET | 35 mg | 3/20/1991 | |
| ORCIGESIC TABLETS | SIN06047P | TABLET, FILM COATED | 35 mg | 5/24/1991 |
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 |
|---|---|---|---|---|---|
| NORGESIC TAB | N/A | N/A | N/A | 4/20/1983 | |
| PARACETAMOL & ORPHENADRINE CITRATE TAB | N/A | synco (h.k.) limited | N/A | N/A | 10/6/2016 |
| PAINREST TABLETS | N/A | N/A | N/A | 12/9/2024 | |
| UNI-PAINGETEX TABLET | N/A | synco (h.k.) limited | N/A | N/A | 1/16/2014 |
| U-NORCETOL TAB | N/A | synco (h.k.) limited | N/A | N/A | 4/13/1987 |
| MYOFLEX TAB | N/A | N/A | N/A | 7/23/2007 | |
| MANGA TABLETS | N/A | N/A | N/A | 12/1/2017 | |
| DIKUTON TAB | N/A | N/A | N/A | 11/12/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NORGESIC paracetamol orphenadrine citrate tablet jar | 10574 | Medicine | A | 7/4/1991 | |
| NORFLEX orphenadrine citrate 100 mg slow release tablet blister pack | 370413 | Medicine | A | 9/29/2021 | |
| NORFLEX orphenadrine citrate 100 mg slow release tablet bottle | 10573 | Medicine | A | 7/4/1991 | |
| Norgesic blister pack | 156623 | Medicine | A | 1/14/2009 |